Panels › Clinical Chemistry › Product code JJY · Class 1
Multi-Analyte Controls, All Kinds (Assayed)
Regulation 862.1660
0510(k)s in 12 months (673 all time)
2recalls in 12 months (95 all time)
73recalls that name a 510(k)
Top companies in JJY
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 61 | 0 |
| Randox Laboratories Limited | 15 | 31 |
| Medical Analysis Systems, Inc. | 31 | 0 |
| Bio-Rad Laboratories | 26 | 1 |
| Roche Diagnostics | 22 | 4 |
| Cliniqa Corporation | 22 | 0 |
| Aalto Scientific, Ltd. | 19 | 0 |
| Maine Standards Co. | 19 | 0 |
| Boehringer Mannheim Corp. | 17 | 0 |
| Casco Standards | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2001 | K012243 | MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL Hematronix, Inc. | JJY |
| Aug 20, 2001 | K012120 | VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 Maine Standards Co. | JJY |
| Aug 20, 2001 | K012119 | VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 Maine Standards Co. | JJY |
| Aug 20, 2001 | K012118 | VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 Maine Standards Co. | JJY |
| Aug 20, 2001 | K012117 | VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 Maine Standards Co. | JJY |
| Jul 17, 2001 | K011853 | ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 Bio-Rad | JJY |
| Jul 12, 2001 | K011867 | LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800 Bio-Rad | JJY |
| Jul 5, 2001 | K011731 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. | JJY |
| Jun 26, 2001 | K011579 | LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 Bio-Rad | JJY |
| Jun 18, 2001 | K011548 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 Medical Analysis Systems, Inc. | JJY |
| Jun 8, 2001 | K011494 | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL Bio-Rad | JJY |
| May 18, 2001 | K011169 | HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 International Enzymes, Inc. | JJY |
| Mar 5, 2001 | K010358 | VIGIL SEROLOGY CONTROL LEVEL C Beckman Coulter, Inc. | JJY |
| Feb 28, 2001 | K010111 | CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK Medical Analysis Systems, Inc. | JJY |
| Dec 20, 2000 | K003716 | CONFORMANCE CHEMISTRY CONTROL C3 Consolidated Technology | JJY |
| Nov 27, 2000 | K003488 | SYNCHRON CONTROL Beckman Coulter, Inc. | JJY |
| Nov 27, 2000 | K002852 | N/T PROTEIN CONTROL SL Dade Behring, Inc. | JJY |
| Nov 2, 2000 | K001249 | QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 Consolidated Technologies of Wisconsin | JJY |
| Aug 31, 2000 | K002460 | LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 Bio-Rad | JJY |
| Aug 22, 2000 | K002174 | DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 Casco-Nerl Diagnostics Corporation (Maine) | JJY |
| Aug 7, 2000 | K002196 | LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 Bio-Rad | JJY |
| Jul 5, 2000 | K001758 | DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) Medical Analysis Systems, Inc. | JJY |
| Jun 19, 2000 | K001632 | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 Avl Scientific Corp. | JJY |
| May 25, 2000 | K001373 | LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 Bio-Rad | JJY |
| Apr 20, 2000 | K000875 | ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 Bio-Rad | JJY |
| Apr 13, 2000 | K000810 | QUALITROL LIPID CONTROL, LEVELS 1 AND 2 Consolidated Technologies of Wisconsin | JJY |
| Mar 7, 2000 | K000270 | ELECSYS CORTISOL TEST SYSTEM Roche Diagnostics Corp. | JJY |
| Feb 15, 2000 | K000116 | QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3 Consolidated Technologies, Inc. | JJY |
| Dec 20, 1999 | K981915 | TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION The Binding Site, Ltd. | JJY |
| Dec 9, 1999 | K993631 | QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 Seracare Technology | JJY |
| Dec 9, 1999 | K992939 | QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 Seracare Technology | JJY |
| Nov 30, 1999 | K993546 | TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 Medical Analysis Systems, Inc. | JJY |
| Nov 30, 1999 | K993310 | APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH Dade Behring, Inc. | JJY |
| Nov 26, 1999 | K993023 | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS Beckman Coulter, Inc. | JJY |
| Nov 26, 1999 | K993014 | MODIFICATION TO DOCUMENT THYROID CAL.VER Casco-Nerl Diagnostics Corporation (Maine) | JJY |
| Nov 24, 1999 | K993360 | PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA Roche Diagnostics Corp. | JJY |
| Nov 24, 1999 | K992900 | PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA Roche Diagnostics Corp. | JJY |
| Nov 24, 1999 | K992710 | ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK Abbott Laboratories | JJY |
| Nov 12, 1999 | K992770 | QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 Seracare Technology | JJY |
| Nov 9, 1999 | K992741 | LYPHOCHEK ANEMIA CONTROL, MODEL 500 Bio-Rad | JJY |
| Sep 2, 1999 | K992172 | LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 Bio-Rad | JJY |
| Aug 24, 1999 | K992349 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | JJY |
| Aug 11, 1999 | K992550 | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 Bio-Rad | JJY |
| Jul 23, 1999 | K992034 | DOCUMENT THYROID CAL*VER Casco-Nerl Diagnostics Corporation (Maine) | JJY |
| Jun 25, 1999 | K991704 | N/T PROTEIN CONTROL LC Dade Behring, Inc. | JJY |
| Jun 11, 1999 | K991447 | CARDIOQUANT CARDIAC ASSESSMENT CONTROLS Spectral Diagnostics, Inc., CA | JJY |
| May 19, 1999 | K991182 | MODIFICATION OF N/T PROTEIN CONTROL SL Dade Behring, Inc. | JJY |
| May 19, 1999 | K990016 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS Ortho-Clinical Diagnostics, Inc. | JJY |
| Apr 27, 1999 | K990610 | ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 Bio-Rad | JJY |
| Apr 7, 1999 | K990888 | MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 Bio-Rad | JJY |
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