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 2 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K062668 | AUDIT MICROCV IMMUNOASSAY LINEARITY SET | Aalto Scientific, Ltd. | 2006-10-16 | Traditional | PDF ↗ |
| K061137 | ADVIA IMS CPSA CONTROL | Bayer Healthcare, LLC | 2006-07-06 | Abbreviated | PDF ↗ |
| K060850 | NOD CHEMISTRY CONTROL | Bioresource Technology, Inc. | 2006-05-30 | Traditional | PDF ↗ |
| K061196 | CARDIOIMMUNE XL CARDIAC MARKER CONTROL | Microgenics Corp. | 2006-05-30 | Traditional | PDF ↗ |
| K061182 | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB | Cliniqa Corporation | 2006-05-25 | Traditional | PDF ↗ |
| K060206 | MISSION COMPLETE | Diamond Diagnostics, Inc. | 2006-03-21 | Traditional | PDF ↗ |
| K060429 | TDM CONTROL SET | Roche Diagnostics Corp. | 2006-03-15 | Abbreviated | PDF ↗ |
| K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET | Maine Standards Co. | 2006-01-13 | Traditional | PDF ↗ |
| K051543 | ELECSYS PRECICONTROL BONE | Roche Diagnostics Corp. | 2005-10-17 | Traditional | PDF ↗ |
| K051928 | AUTOCHECK6+ | Radiometer Medical Aps | 2005-10-12 | Traditional | PDF ↗ |
| K052056 | DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM | Thermo-Electron Corp. | 2005-09-23 | Traditional | PDF ↗ |
| K051687 | ELECSYS PRECICONTROL UNIVERSAL | Roche Diagnostics Corp. | 2005-07-25 | Traditional | PDF ↗ |
| K051185 | ELECSYS CA 19-9 CALCHECK | Roche Diagnostics Corp. | 2005-07-06 | Traditional | PDF ↗ |
| K051517 | ELECSYS PRECICONTROL ANEMIA | Roche Diagnostics Corp. | 2005-07-05 | Traditional | PDF ↗ |
| K050537 | LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS | Bio-Rad | 2005-04-27 | Traditional | PDF ↗ |
| K050387 | ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR | Roche Diagnostics Corp. | 2005-04-25 | Special | PDF ↗ |
| K050504 | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS | Maine Standards Co. | 2005-03-25 | Traditional | PDF ↗ |
| K050536 | QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL | Bio-Rad | 2005-03-24 | Traditional | PDF ↗ |
| K050125 | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 | More Diagnostics | 2005-03-18 | Traditional | PDF ↗ |
| K043208 | LIQUID ASSAYED MULTIQUAL CONTROL | Bio-Rad | 2005-01-07 | Traditional | PDF ↗ |
| K042318 | AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET | Aalto Scientific, Ltd. | 2004-12-09 | Traditional | PDF ↗ |
| K043108 | LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL | Bio-Rad Laboratories, Inc. | 2004-12-07 | Traditional | PDF ↗ |
| K042625 | QUIKREAD CRP CALIBRATOR SET | Orion Diagnostica, OY | 2004-11-18 | Traditional | PDF ↗ |
| K042815 | QUEST TUMOR MARKER CONTROL, MODEL 955 | Bio-Rad | 2004-11-05 | Traditional | PDF ↗ |
| K041975 | VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 | Maine Standards Co. | 2004-10-15 | Traditional | PDF ↗ |
| K042324 | LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 | Bio-Rad | 2004-10-07 | Traditional | PDF ↗ |
| K042335 | ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 | Bio-Rad Laboratories, Inc. | 2004-09-17 | Traditional | PDF ↗ |
| K042389 | MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA | Roche Diagnostics Corp. | 2004-09-14 | Special | PDF ↗ |
| K041361 | RANDOX TRI LEVEL CARDIAC CONTROL | Randox Laboratories Limited | 2004-09-09 | Traditional | PDF ↗ |
| K041812 | MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) | Roche Diagnostics Corp. | 2004-07-27 | Special | PDF ↗ |
| K040459 | TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS | Biosite Incorporated | 2004-07-06 | Traditional | PDF ↗ |
| K040379 | RANDOX IMMUNOASSAY CONTROL | Randox Laboratories, Ltd. | 2004-06-16 | Traditional | PDF ↗ |
| K041227 | MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA | Roche Diagnostics Corp. | 2004-05-27 | Special | PDF ↗ |
| K041073 | DOCUMENT SALICYLATE CAL VER | Microgenics Corp. | 2004-05-21 | Traditional | PDF ↗ |
| K040822 | LIQUICHEK TORCH PLUS IGM CONTROL | Bio-Rad Laboratories, Inc. | 2004-05-19 | Traditional | PDF ↗ |
| K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | Medical Analysis Systems, Inc. | 2004-04-28 | Traditional | PDF ↗ |
| K040925 | NORMAL AND HYPERGAMMA CONTROL SERUM | Sebia | 2004-04-28 | Traditional | PDF ↗ |
| K040352 | NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) | Bioresource Technology, Inc. | 2004-04-02 | Traditional | PDF ↗ |
| K040535 | LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS | Cliniqa Corporation | 2004-03-29 | Traditional | PDF ↗ |
| K040280 | PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS | Roche Diagnostics Corp. | 2004-03-11 | Traditional | PDF ↗ |
| K040277 | LIQUICHEK CARDIAC MARKER CONTROL LT | Bio-Rad Laboratories, Inc. | 2004-03-10 | Traditional | PDF ↗ |
| K040273 | LYPHOCHEK ASSAYED CHEMISTRY CONTROL | Bio-Rad Laboratories, Inc. | 2004-03-04 | Traditional | PDF ↗ |
| K040091 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | Cliniqa Corporation | 2004-02-23 | Traditional | PDF ↗ |
| K033344 | LIGAND PLUS CONTROL LEVEL 1-3 | Consolidated Technology | 2004-01-16 | Traditional | PDF ↗ |
| K033937 | ELECSYS PRECICONTROL MULTIANALYTE | Roche Diagnostics Corp. | 2004-01-07 | Traditional | PDF ↗ |
| K033379 | BAYER SPECIAL CHEMISTRY CONTROLS | Bayer Diagnostics Corp. | 2003-12-19 | Abbreviated | PDF ↗ |
| K033387 | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 | Bio-Rad | 2003-12-02 | Traditional | PDF ↗ |
| K032074 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS | Cliniqa Corporation | 2003-10-21 | Traditional | PDF ↗ |
| K033162 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | Cliniqa Corporation | 2003-10-10 | Traditional | PDF ↗ |
| K032122 | AUDIT MICROCONTROLS MICROFD BNP CONTROL | Aalto Scientific, Ltd. | 2003-09-09 | Traditional | PDF ↗ |
| K032237 | N/T PROTEIN CONTROL | Dade Behring, Inc. | 2003-09-05 | Traditional | PDF ↗ |
| K032453 | ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL | Bionostics, Inc. | 2003-08-28 | Traditional | PDF ↗ |
| K031921 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS | Cliniqa Corporation | 2003-08-25 | Traditional | PDF ↗ |
| K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL | Medical Analysis Systems, Inc. | 2003-08-19 | Traditional | PDF ↗ |
| K031577 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS | Cliniqa Corporation | 2003-08-06 | Traditional | PDF ↗ |
| K032089 | ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC | Roche Diagnostics Corp. | 2003-07-30 | Special | PDF ↗ |
| K031575 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS | Cliniqa Corporation | 2003-07-23 | Traditional | PDF ↗ |
| K031644 | BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL | Bayer Healthcare, LLC | 2003-06-25 | Abbreviated | PDF ↗ |
| K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 | Hemagen Diagnostics, Inc. | 2003-06-16 | Abbreviated | PDF ↗ |
| K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 | Medical Analysis Systems, Inc. | 2003-05-30 | Traditional | PDF ↗ |
| K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL | Medical Analysis Systems, Inc. | 2003-04-28 | Traditional | PDF ↗ |
| K030801 | BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL | Bayer Healthcare, LLC | 2003-04-09 | Abbreviated | PDF ↗ |
| K030705 | CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL | Cliniqa Corporation | 2003-03-26 | Traditional | PDF ↗ |
| K030482 | WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 | Wiener Laboratories | 2003-03-19 | Traditional | PDF ↗ |
| K030679 | MAS LIPID LEVEL 1 AND 2 | Medical Analysis Systems, Inc. | 2003-03-14 | Traditional | PDF ↗ |
| K030566 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS | Cliniqa Corporation | 2003-03-13 | Traditional | PDF ↗ |
| K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | Bayer Diagnostics Corp. | 2003-03-03 | Abbreviated | PDF ↗ |
| K030150 | LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS | Cliniqa Corporation | 2003-01-28 | Traditional | PDF ↗ |
| K030089 | TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS | Biosite Incorporated | 2003-01-23 | Traditional | PDF ↗ |
| K030088 | TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS | Biosite Incorporated | 2003-01-17 | Traditional | PDF ↗ |
| K023410 | VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 | Maine Standards Co. | 2003-01-06 | Traditional | PDF ↗ |
| K023731 | QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 | Consolidated Technology | 2002-12-24 | Traditional | PDF ↗ |
| K023669 | MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA | Medical Analysis Systems, Inc. | 2002-12-19 | Traditional | PDF ↗ |
| K023867 | MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 | Medical Analysis Systems, Inc. | 2002-12-17 | Traditional | PDF ↗ |
| K023661 | LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS | Cliniqa Corporation | 2002-12-06 | Traditional | PDF ↗ |
| K023352 | VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 | Maine Standards Co. | 2002-11-22 | Traditional | PDF ↗ |
| K023250 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE | Cliniqa Corporation | 2002-10-17 | Traditional | PDF ↗ |
| K022867 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE | Cliniqa Corporation | 2002-10-02 | Traditional | PDF ↗ |
| K022885 | LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE | Cliniqa Corporation | 2002-10-02 | Traditional | PDF ↗ |
| K022936 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE | Cliniqa Corporation | 2002-10-02 | Traditional | PDF ↗ |
| K022851 | PH AND AMINES EXTERNAL CONTROL SET | Quidel Corp. | 2002-09-27 | Traditional | PDF ↗ |
| K022991 | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 | Bio-Rad | 2002-09-17 | Traditional | PDF ↗ |
| K022591 | RANDOX LIPID CONTROL | Randox Laboratories, Ltd. | 2002-08-30 | Traditional | PDF ↗ |
| K022401 | PTS PANELS MULTI-CHEMISTRY CONTROLS | Polymer Technology Systems, Inc. | 2002-08-21 | Traditional | PDF ↗ |
| K022041 | LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 | Bio-Rad Laboratories, Inc. | 2002-07-16 | Traditional | PDF ↗ |
| K021930 | MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL | Bionostics, Inc. | 2002-06-25 | Traditional | PDF ↗ |
| K021381 | MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 | Dade Behring, Inc. | 2002-06-10 | Traditional | PDF ↗ |
| K020817 | LIQUICHEK URINE CHEMISTRY CONTROL | Bio-Rad Laboratories, Inc. | 2002-04-12 | Traditional | PDF ↗ |
| K020450 | VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 | Maine Standards Co. | 2002-03-21 | Traditional | PDF ↗ |
| K020237 | IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 | Consolidated Technology | 2002-03-19 | Traditional | PDF ↗ |
| K020521 | MODIFICATION TO VIGIL LIPID CONTROL | Beckman Coulter, Inc. | 2002-03-01 | Special | PDF ↗ |
| K013995 | MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL | Medical Analysis Systems, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K013734 | MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL | Medical Analysis Systems, Inc. | 2001-12-07 | Special | PDF ↗ |
| K013332 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE | Cliniqa Corporation | 2001-11-20 | Traditional | PDF ↗ |
| K013265 | VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 | Maine Standards Co. | 2001-11-20 | Traditional | PDF ↗ |
| K013235 | MODIFICATION TO SYNCHRON CONTROL | Beckman Coulter, Inc. | 2001-10-16 | Special | PDF ↗ |
| K012468 | MODIFICATION TO N/T PROTEIN CONTROL SL | Dade Behring, Inc. | 2001-09-04 | Traditional | PDF ↗ |
| K012855 | LIQUISPX LIQUID LIPID CONTROL | Clinical Controls Division | 2001-08-30 | Traditional | PDF ↗ |
| K012513 | LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 | Bio-Rad | 2001-08-29 | Traditional | PDF ↗ |
| K012431 | COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 | Bionostics, Inc. | 2001-08-28 | Traditional | PDF ↗ |
Product code JJY · Class I · Clinical Chemistry. Data: openFDA.