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 |
|---|---|---|---|
| Mar 31, 1999 | K990424 | ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 Bio-Rad | JJY |
| Mar 18, 1999 | K990394 | ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 Bio-Rad | JJY |
| Mar 18, 1999 | K990317 | ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 Bio-Rad | JJY |
| Mar 15, 1999 | K990391 | ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 Bio-Rad | JJY |
| Mar 12, 1999 | K990531 | VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS Ortho-Clinical Diagnostics, Inc. | JJY |
| Mar 9, 1999 | K990282 | ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 Bio-Rad | JJY |
| Feb 2, 1999 | K984594 | LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 Bio-Rad | JJY |
| Feb 2, 1999 | K984419 | ELECSYS IGE CALCHECK Boehringer Mannheim Corp. | JJY |
| Jan 29, 1999 | K984477 | LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 Bio-Rad | JJY |
| Jan 28, 1999 | K990161 | ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 Bio-Rad | JJY |
| Jan 26, 1999 | K990150 | ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 Bio-Rad | JJY |
| Jan 26, 1999 | K990149 | ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 Bio-Rad | JJY |
| Jan 25, 1999 | K990017 | ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 Bio-Rad | JJY |
| Dec 17, 1998 | K984325 | ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 Bio-Rad | JJY |
| Dec 16, 1998 | K983807 | LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 Bio-Rad | JJY |
| Dec 14, 1998 | K984372 | ELECSYS CALCHECK TROPONIN T Boehringer Mannheim Corp. | JJY |
| Dec 14, 1998 | K984225 | LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 Bio-Rad | JJY |
| Nov 20, 1998 | K984074 | ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 Bio-Rad | JJY |
| Nov 4, 1998 | K983507 | VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY Ortho-Clinical Diagnostics, Inc. | JJY |
| Nov 3, 1998 | K983513 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | JJY |
| Oct 9, 1998 | K983492 | BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC Boehringer Mannheim Corp. | JJY |
| Sep 29, 1998 | K983241 | ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS Kamiya Biomedical Co. | JJY |
| Sep 29, 1998 | K983130 | LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS Kamiya Biomedical Co. | JJY |
| Sep 22, 1998 | K983166 | ELECSYS CALCHECK MYOGLOBIN Boehringer Mannheim Corp. | JJY |
| Aug 12, 1998 | K982637 | IMMULITE PSA CONTROL MODULE, MODEL LPSCM Diagnostic Products Corp. | JJY |
| Aug 12, 1998 | K982473 | TUMOR MARKER CONTROL Diagnostic Products Corp. | JJY |
| Jul 22, 1998 | K982290 | CHEM-CHEX STAT (NEW) Streck Laboratories, Inc. | JJY |
| Jul 9, 1998 | K982224 | VIGIL PROTEIN CONTROL Beckman Coulter, Inc. | JJY |
| May 18, 1998 | K981401 | BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS Boehringer Mannheim Corp. | JJY |
| May 13, 1998 | K981455 | THIRD GENERATION PSA CONTROL MODULE Diagnostic Products Corp. | JJY |
| May 12, 1998 | K981532 | LYPHOCHEK IMMUNOASSAY PLUS CONTROL Bio-Rad | JJY |
| May 7, 1998 | K981474 | CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) Spectral Diagnostics, Inc., CA | JJY |
| Apr 21, 1998 | K981339 | QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 Consolidated Technologies, Inc. | JJY |
| Mar 4, 1998 | K980514 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 Medical Analysis Systems, Inc. | JJY |
| Feb 20, 1998 | K972904 | DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL Casco Standards | JJY |
| Feb 12, 1998 | K980178 | OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY Bionostics, Inc. | JJY |
| Jan 27, 1998 | K974613 | VIROTROL III Blackhawk Biosystems, Inc. | JJY |
| Jan 22, 1998 | K974826 | BM PRECIPATH(R) HDL/LDL-C CONTROL Boehringer Mannheim Corp. | JJY |
| Jan 22, 1998 | K974822 | AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL Avl Scientific Corp. | JJY |
| Jan 8, 1998 | K974827 | TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE Biosite Incorporated | JJY |
| Dec 17, 1997 | K974452 | VIGIL LIPID CONTROL Beckman Instruments, Inc. | JJY |
| Dec 8, 1997 | K974384 | ELECSYS CALCHECK FOLATE Boehringer Mannheim Corp. | JJY |
| Oct 29, 1997 | K973894 | IMMUSURE Quantimetrix Corp. | JJY |
| Oct 14, 1997 | K973791 | ABC CALIBRATION VERIFIERS Sc Calibrators & Controls, LLC | JJY |
| Oct 14, 1997 | K973790 | ABC LINEARITY VERIFIERS Sc Calibrators & Controls, LLC | JJY |
| Oct 7, 1997 | K973629 | PRECINORM RF, PRECIPATH RF Boehringer Mannheim Corp. | JJY |
| Sep 25, 1997 | K973517 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Johnson & Johnson Clinical Diagnostics, Inc. | JJY |
| Sep 25, 1997 | K973469 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS Consolidated Technologies, Inc. | JJY |
| Sep 4, 1997 | K973030 | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) Johnson & Johnson Clinical Diagnostics, Inc. | JJY |
| Aug 28, 1997 | K972868 | TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL Bionostics, Inc. | JJY |
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