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 |
|---|---|---|---|
| Oct 16, 2006 | K062668 | AUDIT MICROCV IMMUNOASSAY LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Jul 6, 2006 | K061137 | ADVIA IMS CPSA CONTROL Bayer Healthcare, LLC | JJY |
| May 30, 2006 | K061196 | CARDIOIMMUNE XL CARDIAC MARKER CONTROL Microgenics Corp. | JJY |
| May 30, 2006 | K060850 | NOD CHEMISTRY CONTROL Bioresource Technology, Inc. | JJY |
| May 25, 2006 | K061182 | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB Cliniqa Corporation | JJY |
| Mar 21, 2006 | K060206 | MISSION COMPLETE Diamond Diagnostics, Inc. | JJY |
| Mar 15, 2006 | K060429 | TDM CONTROL SET Roche Diagnostics Corp. | JJY |
| Jan 13, 2006 | K053247 | VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET Maine Standards Co. | JJY |
| Oct 17, 2005 | K051543 | ELECSYS PRECICONTROL BONE Roche Diagnostics Corp. | JJY |
| Oct 12, 2005 | K051928 | AUTOCHECK6+ Radiometer Medical Aps, DK | JJY |
| Sep 23, 2005 | K052056 | DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM Thermo-Electron Corp., AU | JJY |
| Jul 25, 2005 | K051687 | ELECSYS PRECICONTROL UNIVERSAL Roche Diagnostics Corp. | JJY |
| Jul 6, 2005 | K051185 | ELECSYS CA 19-9 CALCHECK Roche Diagnostics Corp. | JJY |
| Jul 5, 2005 | K051517 | ELECSYS PRECICONTROL ANEMIA Roche Diagnostics Corp. | JJY |
| Apr 27, 2005 | K050537 | LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS Bio-Rad | JJY |
| Apr 25, 2005 | K050387 | ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR Roche Diagnostics Corp. | JJY |
| Mar 25, 2005 | K050504 | VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS Maine Standards Co. | JJY |
| Mar 24, 2005 | K050536 | QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL Bio-Rad | JJY |
| Mar 18, 2005 | K050125 | RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 More Diagnostics | JJY |
| Jan 7, 2005 | K043208 | LIQUID ASSAYED MULTIQUAL CONTROL Bio-Rad | JJY |
| Dec 9, 2004 | K042318 | AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Dec 7, 2004 | K043108 | LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL Bio-Rad Laboratories, Inc. | JJY |
| Nov 18, 2004 | K042625 | QUIKREAD CRP CALIBRATOR SET Orion Diagnostica, OY, FI | JJY |
| Nov 5, 2004 | K042815 | QUEST TUMOR MARKER CONTROL, MODEL 955 Bio-Rad | JJY |
| Oct 15, 2004 | K041975 | VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 Maine Standards Co. | JJY |
| Oct 7, 2004 | K042324 | LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 Bio-Rad | JJY |
| Sep 17, 2004 | K042335 | ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 Bio-Rad Laboratories, Inc. | JJY |
| Sep 14, 2004 | K042389 | MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA Roche Diagnostics Corp. | JJY |
| Sep 9, 2004 | K041361 | RANDOX TRI LEVEL CARDIAC CONTROL Randox Laboratories Limited, GB | JJY |
| Jul 27, 2004 | K041812 | MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) Roche Diagnostics Corp. | JJY |
| Jul 6, 2004 | K040459 | TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS Biosite Incorporated | JJY |
| Jun 16, 2004 | K040379 | RANDOX IMMUNOASSAY CONTROL Randox Laboratories, Ltd., GB | JJY |
| May 27, 2004 | K041227 | MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA Roche Diagnostics Corp. | JJY |
| May 21, 2004 | K041073 | DOCUMENT SALICYLATE CAL VER Microgenics Corp. | JJY |
| May 19, 2004 | K040822 | LIQUICHEK TORCH PLUS IGM CONTROL Bio-Rad Laboratories, Inc. | JJY |
| Apr 28, 2004 | K040925 | NORMAL AND HYPERGAMMA CONTROL SERUM Sebia | JJY |
| Apr 28, 2004 | K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 Medical Analysis Systems, Inc. | JJY |
| Apr 2, 2004 | K040352 | NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) Bioresource Technology, Inc. | JJY |
| Mar 29, 2004 | K040535 | LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS Cliniqa Corporation | JJY |
| Mar 11, 2004 | K040280 | PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS Roche Diagnostics Corp. | JJY |
| Mar 10, 2004 | K040277 | LIQUICHEK CARDIAC MARKER CONTROL LT Bio-Rad Laboratories, Inc. | JJY |
| Mar 4, 2004 | K040273 | LYPHOCHEK ASSAYED CHEMISTRY CONTROL Bio-Rad Laboratories, Inc. | JJY |
| Feb 23, 2004 | K040091 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation | JJY |
| Jan 16, 2004 | K033344 | LIGAND PLUS CONTROL LEVEL 1-3 Consolidated Technology | JJY |
| Jan 7, 2004 | K033937 | ELECSYS PRECICONTROL MULTIANALYTE Roche Diagnostics Corp. | JJY |
| Dec 19, 2003 | K033379 | BAYER SPECIAL CHEMISTRY CONTROLS Bayer Diagnostics Corp. | JJY |
| Dec 2, 2003 | K033387 | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 Bio-Rad | JJY |
| Oct 21, 2003 | K032074 | LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS Cliniqa Corporation | JJY |
| Oct 10, 2003 | K033162 | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation | JJY |
| Sep 9, 2003 | K032122 | AUDIT MICROCONTROLS MICROFD BNP CONTROL Aalto Scientific, Ltd. | JJY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.