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 |
|---|---|---|---|
| Sep 5, 2003 | K032237 | N/T PROTEIN CONTROL Dade Behring, Inc. | JJY |
| Aug 28, 2003 | K032453 | ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL Bionostics, Inc. | JJY |
| Aug 25, 2003 | K031921 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS Cliniqa Corporation | JJY |
| Aug 19, 2003 | K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL Medical Analysis Systems, Inc. | JJY |
| Aug 6, 2003 | K031577 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS Cliniqa Corporation | JJY |
| Jul 30, 2003 | K032089 | ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC Roche Diagnostics Corp. | JJY |
| Jul 23, 2003 | K031575 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS Cliniqa Corporation | JJY |
| Jun 25, 2003 | K031644 | BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL Bayer Healthcare, LLC | JJY |
| Jun 16, 2003 | K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 Hemagen Diagnostics, Inc. | JJY |
| May 30, 2003 | K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 Medical Analysis Systems, Inc. | JJY |
| Apr 28, 2003 | K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL Medical Analysis Systems, Inc. | JJY |
| Apr 9, 2003 | K030801 | BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL Bayer Healthcare, LLC | JJY |
| Mar 26, 2003 | K030705 | CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL Cliniqa Corporation | JJY |
| Mar 19, 2003 | K030482 | WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 Wiener Laboratories, AR | JJY |
| Mar 14, 2003 | K030679 | MAS LIPID LEVEL 1 AND 2 Medical Analysis Systems, Inc. | JJY |
| Mar 13, 2003 | K030566 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS Cliniqa Corporation | JJY |
| Mar 3, 2003 | K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS Bayer Diagnostics Corp. | JJY |
| Jan 28, 2003 | K030150 | LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS Cliniqa Corporation | JJY |
| Jan 23, 2003 | K030089 | TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS Biosite Incorporated | JJY |
| Jan 17, 2003 | K030088 | TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS Biosite Incorporated | JJY |
| Jan 6, 2003 | K023410 | VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 Maine Standards Co. | JJY |
| Dec 24, 2002 | K023731 | QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 Consolidated Technology | JJY |
| Dec 19, 2002 | K023669 | MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA Medical Analysis Systems, Inc. | JJY |
| Dec 17, 2002 | K023867 | MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 Medical Analysis Systems, Inc. | JJY |
| Dec 6, 2002 | K023661 | LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS Cliniqa Corporation | JJY |
| Nov 22, 2002 | K023352 | VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 Maine Standards Co. | JJY |
| Oct 17, 2002 | K023250 | LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE Cliniqa Corporation | JJY |
| Oct 2, 2002 | K022936 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation | JJY |
| Oct 2, 2002 | K022885 | LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation | JJY |
| Oct 2, 2002 | K022867 | LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE Cliniqa Corporation | JJY |
| Sep 27, 2002 | K022851 | PH AND AMINES EXTERNAL CONTROL SET Quidel Corp. | JJY |
| Sep 17, 2002 | 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 | JJY |
| Aug 30, 2002 | K022591 | RANDOX LIPID CONTROL Randox Laboratories, Ltd., GB | JJY |
| Aug 21, 2002 | K022401 | PTS PANELS MULTI-CHEMISTRY CONTROLS Polymer Technology Systems, Inc. | JJY |
| Jul 16, 2002 | K022041 | LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 Bio-Rad Laboratories, Inc. | JJY |
| Jun 25, 2002 | K021930 | MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL Bionostics, Inc. | JJY |
| Jun 10, 2002 | K021381 | MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 Dade Behring, Inc. | JJY |
| Apr 12, 2002 | K020817 | LIQUICHEK URINE CHEMISTRY CONTROL Bio-Rad Laboratories, Inc. | JJY |
| Mar 21, 2002 | K020450 | VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 Maine Standards Co. | JJY |
| Mar 19, 2002 | K020237 | IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 Consolidated Technology | JJY |
| Mar 1, 2002 | K020521 | MODIFICATION TO VIGIL LIPID CONTROL Beckman Coulter, Inc. | JJY |
| Dec 21, 2001 | K013995 | MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL Medical Analysis Systems, Inc. | JJY |
| Dec 7, 2001 | K013734 | MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL Medical Analysis Systems, Inc. | JJY |
| Nov 20, 2001 | K013332 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE Cliniqa Corporation | JJY |
| Nov 20, 2001 | K013265 | VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 Maine Standards Co. | JJY |
| Oct 16, 2001 | K013235 | MODIFICATION TO SYNCHRON CONTROL Beckman Coulter, Inc. | JJY |
| Sep 4, 2001 | K012468 | MODIFICATION TO N/T PROTEIN CONTROL SL Dade Behring, Inc. | JJY |
| Aug 30, 2001 | K012855 | LIQUISPX LIQUID LIPID CONTROL Clinical Controls Division | JJY |
| Aug 29, 2001 | K012513 | LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 Bio-Rad | JJY |
| Aug 28, 2001 | K012431 | COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 Bionostics, Inc. | JJY |
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