FDA Product Code
FDA Product Code JJY — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 673 records · page 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162530 | Multichem IA Plus | Techno-Path Manufacturing | 2017-03-31 | Abbreviated | PDF ↗ |
| K163629 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | 2017-03-10 | Traditional | PDF ↗ |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Bio-Rad Laboratories | 2017-01-10 | Traditional | PDF ↗ |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | Radiometer America, Inc. | 2016-01-28 | Traditional | PDF ↗ |
| K150300 | Liquichek Cardiac Markers Plus Control LT | Bio-Rad Laboratories | 2015-12-11 | Traditional | PDF ↗ |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2015-04-30 | Traditional | PDF ↗ |
| K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories | 2015-03-13 | Traditional | PDF ↗ |
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | 2015-01-16 | Traditional | PDF ↗ |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | Randox Laboratories Limited | 2014-12-08 | Traditional | PDF ↗ |
| K142978 | Audit MicroControls Linearity LQ Special Diabetes | Aalto Scientific, Ltd. | 2014-11-20 | Traditional | PDF ↗ |
| K133676 | ABX PENTRA MICRO ALB CONTROL L/H | HORIBA ABX SAS | 2014-07-11 | Abbreviated | PDF ↗ |
| K141073 | LIQUICHEK TUMOR MARKER CONTROL | Bio-Rad Laboratories | 2014-06-23 | Traditional | PDF ↗ |
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL | Randox Laboratories Limited | 2014-05-22 | Traditional | PDF ↗ |
| K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | Bio-Rad Laboratories | 2014-05-06 | Traditional | PDF ↗ |
| K140764 | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK | Bio-Rad Laboratories | 2014-04-25 | Traditional | PDF ↗ |
| K134013 | LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO | Bio-Rad Laboratories | 2014-04-24 | Traditional | PDF ↗ |
| K140393 | RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 | Randox Laboratories Limited | 2014-03-25 | Traditional | PDF ↗ |
| K133960 | LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL | Bio-Rad Laboratories | 2014-01-22 | Traditional | PDF ↗ |
| K132227 | LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY | Bio-Rad Laboratories | 2013-10-25 | Traditional | PDF ↗ |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | Randox Laboratories, Ltd. | 2013-10-23 | Traditional | PDF ↗ |
| K132751 | MULTICHEM S PLUS / S PLUS (ASSAYED) | Techno-Path Manufacturing , Ltd. | 2013-10-22 | Abbreviated | PDF ↗ |
| K131993 | MULTICHEM U | Techno-Path Manufacturing , Ltd. | 2013-10-15 | Abbreviated | PDF ↗ |
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | Helena Laboratories | 2013-10-07 | Traditional | PDF ↗ |
| K131992 | MULTICHEM P | Techno-Path Manufacturing , Ltd. | 2013-09-25 | Abbreviated | PDF ↗ |
| K132091 | MULTICHEM IA AND IA PLUS | Techno-Path Manufacturing , Ltd. | 2013-09-20 | Abbreviated | PDF ↗ |
| K131595 | EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM | Eurotrol B.V. | 2013-07-26 | Traditional | PDF ↗ |
| K130337 | RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3 | Randox Laboratories Limited | 2013-06-19 | Traditional | PDF ↗ |
| K130963 | LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK | Bio-Rad Laboratories, Inc. | 2013-05-06 | Traditional | PDF ↗ |
| K130762 | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET | Aalto Scientific, Ltd. | 2013-04-29 | Traditional | PDF ↗ |
| K124009 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C | Diamond Diagnostics, Inc. | 2013-04-17 | Traditional | PDF ↗ |
| K130761 | LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK | Bio-Rad Laboratories | 2013-04-12 | Traditional | PDF ↗ |
| K123725 | FASTPACK CONTROL KIT | Qualigen, Inc. | 2013-03-08 | Traditional | PDF ↗ |
| K130162 | LIQUID ASSAYED MULTIQUAL PREMIUM | Bio-Rad Laboratories | 2013-03-01 | Traditional | PDF ↗ |
| K123775 | LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK | Bio-Rad Laboratories | 2013-01-31 | Traditional | PDF ↗ |
| K123663 | LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK | Bio-Rad Laboratories | 2012-12-27 | Traditional | PDF ↗ |
| K121603 | RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 | Randox Laboratories, Ltd. | 2012-11-20 | Traditional | PDF ↗ |
| K123198 | LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA | Bio-Rad Laboratories | 2012-11-20 | Traditional | PDF ↗ |
| K122838 | LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK | Bio-Rad Laboratories | 2012-10-17 | Traditional | PDF ↗ |
| K113720 | RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 | Randox Laboratories, Ltd. | 2012-09-20 | Traditional | PDF ↗ |
| K122291 | THERMO SCIENTIFIC MAS OMNI-CARDIO | Microgenics Corporation | 2012-08-31 | Traditional | PDF ↗ |
| K121759 | CONE-TROL LIQUID CHEMISTRY CONTROLS | Cone Bioproducts | 2012-07-24 | Abbreviated | PDF ↗ |
| K121794 | LIQUICHEK URINE CHEMISTRY CONTROL | Bio-Rad, Diagnostics Grp. | 2012-07-11 | Traditional | PDF ↗ |
| K121468 | EUROTROL GAS-ISE METABOLITES | Eurotrol B.V. | 2012-06-22 | Traditional | PDF ↗ |
| K112742 | AUDIT MICROLQ SPINAL FLUID CONTROL | Aalto Scientific, Ltd. | 2012-06-15 | Traditional | PDF ↗ |
| K111964 | AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY | Aalto Scientific, Ltd. | 2012-03-02 | Traditional | PDF ↗ |
| K112705 | AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL | Aalto Scientific, Ltd. | 2012-01-24 | Traditional | PDF ↗ |
| K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 | Randox Laboratories Limited | 2012-01-23 | Traditional | PDF ↗ |
| K112337 | RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL | Randox Laboratories, Ltd. | 2011-12-01 | Traditional | PDF ↗ |
| K101863 | IT/IF CONTROL | Sebia | 2011-11-07 | Traditional | PDF ↗ |
| K110738 | THERMO SCIENTIFIC MAS OMNI-CORE | Microgenics Corporation | 2011-11-03 | Traditional | PDF ↗ |
| K110904 | RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 | Randox Laboratories, Ltd. | 2011-09-30 | Traditional | PDF ↗ |
| K111996 | ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 | Elitechgroup | 2011-09-14 | Abbreviated | PDF ↗ |
| K111506 | ELECSYS PRECICONTROL VARIA 3 | Roche Diagnostics | 2011-07-08 | Traditional | PDF ↗ |
| K110880 | VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT | Maine Standards Company, LLC | 2011-07-05 | Traditional | PDF ↗ |
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO | Microgenics Corp. | 2011-06-29 | Traditional | PDF ↗ |
| K111063 | VITAL SERUM CONTROLS | Vital Diagnostics (Manufacturing) Ptyltd | 2011-06-28 | Traditional | PDF ↗ |
| K103601 | AUDIT MICROCV IMMUNOASSAY LINEARITY SET | Aalto Scientific, Ltd. | 2011-06-10 | Traditional | PDF ↗ |
| K103364 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL | Diamond Diagnostics, Inc. | 2011-05-06 | Traditional | PDF ↗ |
| K103271 | MSC LIPID CONTROL | Maine Standards Co. | 2011-01-25 | Traditional | PDF ↗ |
| K101216 | AUDIT MICROCV PROTEIN LINEARITY SET | Aalto Scientific, Ltd. | 2011-01-14 | Traditional | PDF ↗ |
| K102617 | AUDIT MICROCV CARDIAC MARKERS LINEARITY SET | Aalto Scientific, Ltd. | 2011-01-10 | Traditional | PDF ↗ |
| K102700 | LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS | Alere, San Diego, Dba Biosite INcorporated, Dba IN | 2010-12-21 | Traditional | PDF ↗ |
| K101809 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 | Fujirebio Diagnostics,Inc. | 2010-10-05 | Traditional | PDF ↗ |
| K100727 | LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK | Bio-Rad, Diagnostics Grp. | 2010-09-14 | Traditional | PDF ↗ |
| K100718 | AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 | Aalto Scientific, Ltd. | 2010-09-03 | Traditional | PDF ↗ |
| K102016 | PRECICONTROL CLINCHEM MULTI 1 AND 2 | Roche Diagnostics | 2010-09-01 | Traditional | PDF ↗ |
| K101226 | AUDIT MICROCV RF/CRP LINEARITY SET | Aalto Scientific, Ltd. | 2010-08-31 | Traditional | PDF ↗ |
| K102157 | ELECSYS PRECICONTROL MULTIMARKER | Roche Diagnostics | 2010-08-27 | Traditional | PDF ↗ |
| K101633 | NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH | Nova Biomedical Corp. | 2010-08-27 | Traditional | PDF ↗ |
| K093492 | MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR | Diamond Diagnostics, Inc. | 2010-03-19 | Traditional | PDF ↗ |
| K093384 | MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) | Diamond Diagnostics, Inc. | 2010-03-10 | Traditional | PDF ↗ |
| K093032 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET | Biosite Incorporated | 2009-11-13 | Traditional | PDF ↗ |
| K092320 | ELECSYS PRECICONTROL THYROAB | Roche Diagnostics | 2009-11-03 | Traditional | PDF ↗ |
| K092051 | THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 | Microgenics Corp. | 2009-09-21 | Traditional | PDF ↗ |
| K090541 | ELECSYS PRECICONTROL UNIVERSAL | Roche Diagnostics | 2009-07-02 | Traditional | PDF ↗ |
| K091225 | VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET | Maine Standards Co. | 2009-06-25 | Traditional | PDF ↗ |
| K083554 | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 | Cliniqa Corporation | 2009-04-21 | Traditional | PDF ↗ |
| K090475 | VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 | Maine Standards Co. | 2009-04-16 | Traditional | PDF ↗ |
| K083891 | VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 | Maine Standards Co. | 2009-03-23 | Traditional | PDF ↗ |
| K082714 | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 | Aalto Scientific, Ltd. | 2008-11-19 | Traditional | PDF ↗ |
| K082717 | AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 | Aalto Scientific, Ltd. | 2008-10-30 | Traditional | PDF ↗ |
| K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | Cliniqa Corporation | 2008-09-17 | Traditional | PDF ↗ |
| K082036 | LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK | Bio-Rad Laboratories | 2008-09-08 | Traditional | PDF ↗ |
| K082067 | MSC LIPID CONTROL | Maine Standards Co. | 2008-08-22 | Traditional | PDF ↗ |
| K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | Cliniqa Corporation | 2008-06-02 | Traditional | PDF ↗ |
| K073080 | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 | Bio-Rad Laboratories | 2008-01-24 | Traditional | PDF ↗ |
| K072835 | LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK | Bio-Rad, Diagnostics Grp. | 2007-12-11 | Traditional | PDF ↗ |
| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | Biosite Incorporated | 2007-12-07 | Traditional | PDF ↗ |
| K072246 | VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 | Maine Standards Co. | 2007-09-14 | Traditional | PDF ↗ |
| K071980 | DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H | Dade Behring, Inc. | 2007-09-11 | Traditional | PDF ↗ |
| K071675 | LIQUICHEK TUMOR MARKER CONTROL | Bio-Rad Laboratories | 2007-07-03 | Traditional | PDF ↗ |
| K071433 | SMS GLUCOSE CONTROL, MODEL 2120059 | Specialty Medical Supplies | 2007-06-28 | Traditional | PDF ↗ |
| K070741 | CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 | Cliniqa Corporation | 2007-05-04 | Traditional | PDF ↗ |
| K070504 | AMMONIA/ALCOHOL CONTROL SET | Pointe Scientific, Inc., | 2007-04-11 | Abbreviated | PDF ↗ |
| K070200 | TDM CONTROL SET, MODEL CAT# 04521536 | Roche Diagnostics Corp. | 2007-03-19 | Special | PDF ↗ |
| K070223 | AUDIT MICROCV LIPIDS LINEARITY SET (LOW) | Aalto Scientific, Ltd. | 2007-03-13 | Traditional | PDF ↗ |
| K062379 | COBAS INTEGRA CERULOPLASMIN | Roche Diagnostics Corp. | 2007-01-31 | Traditional | PDF ↗ |
| K062674 | MISSION TRINITY B | Diamond Diagnostics, Inc. | 2006-12-01 | Traditional | PDF ↗ |
| K062593 | CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET | Compass Bioscience | 2006-11-22 | Traditional | PDF ↗ |
| K062916 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 | Cliniqa Corporation | 2006-10-23 | Traditional | PDF ↗ |
Product code JJY · Class I · Clinical Chemistry. Data: openFDA.