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 3 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K012243 | MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL | Hematronix, Inc. | 2001-08-20 | Traditional | PDF ↗ |
| K012117 | VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 | Maine Standards Co. | 2001-08-20 | Traditional | PDF ↗ |
| K012118 | VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 | Maine Standards Co. | 2001-08-20 | Traditional | PDF ↗ |
| K012120 | VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 | Maine Standards Co. | 2001-08-20 | Traditional | PDF ↗ |
| K012119 | VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 | Maine Standards Co. | 2001-08-20 | Traditional | PDF ↗ |
| K011853 | ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 | Bio-Rad | 2001-07-17 | Traditional | PDF ↗ |
| K011867 | LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 | Bio-Rad | 2001-07-12 | Traditional | PDF ↗ |
| K011731 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 2001-07-05 | Traditional | PDF ↗ |
| K011579 | LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 | Bio-Rad | 2001-06-26 | Traditional | PDF ↗ |
| K011548 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 | Medical Analysis Systems, Inc. | 2001-06-18 | Traditional | PDF ↗ |
| K011494 | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL | Bio-Rad | 2001-06-08 | Traditional | PDF ↗ |
| K011169 | HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 | International Enzymes, Inc. | 2001-05-18 | Traditional | PDF ↗ |
| K010358 | VIGIL SEROLOGY CONTROL LEVEL C | Beckman Coulter, Inc. | 2001-03-05 | Traditional | PDF ↗ |
| K010111 | CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK | Medical Analysis Systems, Inc. | 2001-02-28 | Traditional | PDF ↗ |
| K003716 | CONFORMANCE CHEMISTRY CONTROL C3 | Consolidated Technology | 2000-12-20 | Traditional | PDF ↗ |
| K003488 | SYNCHRON CONTROL | Beckman Coulter, Inc. | 2000-11-27 | Special | PDF ↗ |
| K002852 | N/T PROTEIN CONTROL SL | Dade Behring, Inc. | 2000-11-27 | Traditional | PDF ↗ |
| K001249 | QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 | Consolidated Technologies of Wisconsin | 2000-11-02 | Traditional | PDF ↗ |
| K002460 | LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 | Bio-Rad | 2000-08-31 | Traditional | PDF ↗ |
| K002174 | DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 | Casco-Nerl Diagnostics Corporation (Maine) | 2000-08-22 | Traditional | PDF ↗ |
| K002196 | LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 | Bio-Rad | 2000-08-07 | Traditional | PDF ↗ |
| K001758 | DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) | Medical Analysis Systems, Inc. | 2000-07-05 | Traditional | PDF ↗ |
| K001632 | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 | Avl Scientific Corp. | 2000-06-19 | Traditional | PDF ↗ |
| K001373 | LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 | Bio-Rad | 2000-05-25 | Traditional | PDF ↗ |
| K000875 | ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 | Bio-Rad | 2000-04-20 | Traditional | PDF ↗ |
| K000810 | QUALITROL LIPID CONTROL, LEVELS 1 AND 2 | Consolidated Technologies of Wisconsin | 2000-04-13 | Traditional | PDF ↗ |
| K000270 | ELECSYS CORTISOL TEST SYSTEM | Roche Diagnostics Corp. | 2000-03-07 | Traditional | PDF ↗ |
| K000116 | QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 | Consolidated Technologies, Inc. | 2000-02-15 | Traditional | PDF ↗ |
| K981915 | TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION | The Binding Site, Ltd. | 1999-12-20 | Traditional | PDF ↗ |
| K992939 | QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 | Seracare Technology | 1999-12-09 | Traditional | PDF ↗ |
| K993631 | QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 | Seracare Technology | 1999-12-09 | Traditional | PDF ↗ |
| K993546 | TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 | Medical Analysis Systems, Inc. | 1999-11-30 | Traditional | PDF ↗ |
| K993310 | APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH | Dade Behring, Inc. | 1999-11-30 | Traditional | PDF ↗ |
| K993023 | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS | Beckman Coulter, Inc. | 1999-11-26 | Traditional | PDF ↗ |
| K993014 | MODIFICATION TO DOCUMENT THYROID CAL.VER | Casco-Nerl Diagnostics Corporation (Maine) | 1999-11-26 | Traditional | PDF ↗ |
| K992900 | PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA | Roche Diagnostics Corp. | 1999-11-24 | Traditional | PDF ↗ |
| K992710 | ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK | Abbott Laboratories | 1999-11-24 | Traditional | PDF ↗ |
| K993360 | PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA | Roche Diagnostics Corp. | 1999-11-24 | Traditional | PDF ↗ |
| K992770 | QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 | Seracare Technology | 1999-11-12 | Traditional | PDF ↗ |
| K992741 | LYPHOCHEK ANEMIA CONTROL, MODEL 500 | Bio-Rad | 1999-11-09 | Traditional | PDF ↗ |
| K992172 | LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 | Bio-Rad | 1999-09-02 | Traditional | PDF ↗ |
| K992349 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 1999-08-24 | Traditional | PDF ↗ |
| K992550 | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 | Bio-Rad | 1999-08-11 | Traditional | PDF ↗ |
| K992034 | DOCUMENT THYROID CAL*VER | Casco-Nerl Diagnostics Corporation (Maine) | 1999-07-23 | Traditional | PDF ↗ |
| K991704 | N/T PROTEIN CONTROL LC | Dade Behring, Inc. | 1999-06-25 | Traditional | PDF ↗ |
| K991447 | CARDIOQUANT CARDIAC ASSESSMENT CONTROLS | Spectral Diagnostics, Inc. | 1999-06-11 | Traditional | PDF ↗ |
| K990016 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS | Ortho-Clinical Diagnostics, Inc. | 1999-05-19 | Traditional | PDF ↗ |
| K991182 | MODIFICATION OF N/T PROTEIN CONTROL SL | Dade Behring, Inc. | 1999-05-19 | Traditional | PDF ↗ |
| K990610 | ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 | Bio-Rad | 1999-04-27 | Traditional | PDF ↗ |
| K990888 | MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 | Bio-Rad | 1999-04-07 | Traditional | PDF ↗ |
| K990424 | ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 | Bio-Rad | 1999-03-31 | Traditional | PDF ↗ |
| K990317 | ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 | Bio-Rad | 1999-03-18 | Traditional | PDF ↗ |
| K990394 | ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 | Bio-Rad | 1999-03-18 | Traditional | PDF ↗ |
| K990391 | ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 | Bio-Rad | 1999-03-15 | Traditional | PDF ↗ |
| K990531 | VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS | Ortho-Clinical Diagnostics, Inc. | 1999-03-12 | Traditional | PDF ↗ |
| K990282 | ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 | Bio-Rad | 1999-03-09 | Traditional | PDF ↗ |
| K984594 | LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 | Bio-Rad | 1999-02-02 | Traditional | PDF ↗ |
| K984419 | ELECSYS IGE CALCHECK | Boehringer Mannheim Corp. | 1999-02-02 | Traditional | PDF ↗ |
| K984477 | LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 | Bio-Rad | 1999-01-29 | Traditional | PDF ↗ |
| K990161 | ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 | Bio-Rad | 1999-01-28 | Traditional | PDF ↗ |
| K990150 | ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 | Bio-Rad | 1999-01-26 | Traditional | PDF ↗ |
| K990149 | ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 | Bio-Rad | 1999-01-26 | Traditional | PDF ↗ |
| K990017 | ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 | Bio-Rad | 1999-01-25 | Traditional | PDF ↗ |
| K984325 | ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 | Bio-Rad | 1998-12-17 | Traditional | PDF ↗ |
| K983807 | LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 | Bio-Rad | 1998-12-16 | Traditional | PDF ↗ |
| K984372 | ELECSYS CALCHECK TROPONIN T | Boehringer Mannheim Corp. | 1998-12-14 | Traditional | PDF ↗ |
| K984225 | LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 | Bio-Rad | 1998-12-14 | Traditional | PDF ↗ |
| K984074 | ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 | Bio-Rad | 1998-11-20 | Traditional | PDF ↗ |
| K983507 | VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-11-04 | Traditional | PDF ↗ |
| K983513 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K983492 | BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC | Boehringer Mannheim Corp. | 1998-10-09 | Traditional | PDF ↗ |
| K983130 | LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS | Kamiya Biomedical Co. | 1998-09-29 | Traditional | PDF ↗ |
| K983241 | ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS | Kamiya Biomedical Co. | 1998-09-29 | Traditional | PDF ↗ |
| K983166 | ELECSYS CALCHECK MYOGLOBIN | Boehringer Mannheim Corp. | 1998-09-22 | Traditional | PDF ↗ |
| K982473 | TUMOR MARKER CONTROL | Diagnostic Products Corp. | 1998-08-12 | Special | PDF ↗ |
| K982637 | IMMULITE PSA CONTROL MODULE, MODEL LPSCM | Diagnostic Products Corp. | 1998-08-12 | Special | PDF ↗ |
| K982290 | CHEM-CHEX STAT (NEW) | Streck Laboratories, Inc. | 1998-07-22 | Traditional | PDF ↗ |
| K982224 | VIGIL PROTEIN CONTROL | Beckman Coulter, Inc. | 1998-07-09 | Traditional | PDF ↗ |
| K981401 | BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS | Boehringer Mannheim Corp. | 1998-05-18 | Traditional | PDF ↗ |
| K981455 | THIRD GENERATION PSA CONTROL MODULE | Diagnostic Products Corp. | 1998-05-13 | Special | PDF ↗ |
| K981532 | LYPHOCHEK IMMUNOASSAY PLUS CONTROL | Bio-Rad | 1998-05-12 | Traditional | PDF ↗ |
| K981474 | CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) | Spectral Diagnostics, Inc. | 1998-05-07 | Traditional | PDF ↗ |
| K981339 | QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 | Consolidated Technologies, Inc. | 1998-04-21 | Traditional | PDF ↗ |
| K980514 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 | Medical Analysis Systems, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K972904 | DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL | Casco Standards | 1998-02-20 | Traditional | PDF ↗ |
| K980178 | OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY | Bionostics, Inc. | 1998-02-12 | Traditional | PDF ↗ |
| K974613 | VIROTROL III | Blackhawk Biosystems, Inc. | 1998-01-27 | Traditional | PDF ↗ |
| K974826 | BM PRECIPATH(R) HDL/LDL-C CONTROL | Boehringer Mannheim Corp. | 1998-01-22 | Traditional | PDF ↗ |
| K974822 | AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL | Avl Scientific Corp. | 1998-01-22 | Traditional | PDF ↗ |
| K974827 | TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE | Biosite Incorporated | 1998-01-08 | Traditional | PDF ↗ |
| K974452 | VIGIL LIPID CONTROL | Beckman Instruments, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K974384 | ELECSYS CALCHECK FOLATE | Boehringer Mannheim Corp. | 1997-12-08 | Traditional | PDF ↗ |
| K973894 | IMMUSURE | Quantimetrix Corp. | 1997-10-29 | Traditional | PDF ↗ |
| K973790 | ABC LINEARITY VERIFIERS | Sc Calibrators & Controls, LLC | 1997-10-14 | Traditional | PDF ↗ |
| K973791 | ABC CALIBRATION VERIFIERS | Sc Calibrators & Controls, LLC | 1997-10-14 | Traditional | PDF ↗ |
| K973629 | PRECINORM RF, PRECIPATH RF | Boehringer Mannheim Corp. | 1997-10-07 | Traditional | PDF ↗ |
| K973469 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS | Consolidated Technologies, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K973517 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K973030 | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-04 | Traditional | PDF ↗ |
| K972868 | TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL | Bionostics, Inc. | 1997-08-28 | Traditional | PDF ↗ |
Product code JJY · Class I · Clinical Chemistry. Data: openFDA.