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 12, 1997 | K972235 | PRECICONTROL TUMOR MARKER 1 AND 2 Boehringer Mannheim Corp. | JJY |
| Aug 12, 1997 | K972048 | ACCURUN 117 HBEAG POSITIVE CONTROL Boston Biomedica, Inc. | JJY |
| Aug 12, 1997 | K971657 | ACCURUN 121 HAV IGM POSITIVE CONTROL Boston Biomedica, Inc. | JJY |
| Aug 7, 1997 | K972307 | ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL Boston Biomedica, Inc. | JJY |
| Aug 7, 1997 | K971406 | ACCURUN 120 HAV IGG POSITIVE CONTROL Boston Biomedica, Inc. | JJY |
| Aug 4, 1997 | K972608 | RANDOX ASSAYED SPECIFIC PROTEIN CONTROL Randox Laboratories, Ltd., IE | JJY |
| Jun 26, 1997 | K972070 | NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS Nichols Institute Diagnostics | JJY |
| Jun 24, 1997 | K972214 | ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) Roche Diagnostic Systems, Inc. | JJY |
| Jun 18, 1997 | K972080 | QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 Consolidated Technologies, Inc. | JJY |
| Jun 16, 1997 | K971952 | LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) Bio-Rad | JJY |
| Jun 16, 1997 | K971405 | SPECIALITY URINE 1,2 Chiron Diagnostics Corp. | JJY |
| Jun 11, 1997 | K971954 | LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) Bio-Rad | JJY |
| Apr 23, 1997 | K971071 | LIQUID LIGAND 1,2,3 Chiron Diagnostics Corp. | JJY |
| Apr 8, 1997 | K970956 | CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 Chiron Diagnostics Corp. | JJY |
| Apr 8, 1997 | K970862 | SPINALSCOPICS Quantimetrix Corp. | JJY |
| Apr 2, 1997 | K970979 | LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 Chiron Diagnostics Corp. | JJY |
| Apr 2, 1997 | K970976 | CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 Medical Analysis Systems, Inc. | JJY |
| Feb 20, 1997 | K965114 | TUMOR MARKER CONTROL Diagnostic Products Corp. | JJY |
| Feb 10, 1997 | K970147 | ELECSYS CALCHECK PROLACTIN Boehringer Mannheim Corp. | JJY |
| Jan 27, 1997 | K965048 | VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015) Johnson & Johnson Clinical Diagnostics, Inc. | JJY |
| Jan 13, 1997 | K965171 | LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) Bio-Rad | JJY |
| Dec 13, 1996 | K964640 | CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 Canyon Diagnostics, Inc. | JJY |
| Dec 5, 1996 | K963770 | BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS Biocircuits Corp. | JJY |
| Nov 6, 1996 | K964065 | N/T PROTEIN CONTROL SL Behring Diagnostics, Inc. | JJY |
| Sep 16, 1996 | K961941 | LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 Bio-Rad | JJY |
| Sep 13, 1996 | K961359 | LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 Bioprocessing, Inc. | JJY |
| Sep 9, 1996 | K963346 | STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 Consolidated Technologies, Inc. | JJY |
| Aug 23, 1996 | K962982 | NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT Nova Biomedical Corp. | JJY |
| Aug 15, 1996 | K962997 | NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 Nova Biomedical Corp. | JJY |
| Aug 15, 1996 | K961912 | QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET Consolidated Technologies, Inc. | JJY |
| Jul 22, 1996 | K962630 | DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL Casco Standards | JJY |
| Jul 22, 1996 | K962575 | ELECSYS PRECICONTROL CARDIAC Boehringer Mannheim Corp. | JJY |
| Jul 22, 1996 | K961750 | DOCUMENT CARDIAC ASSAYED CONTROL Casco Standards | JJY |
| May 15, 1996 | K961195 | CHEM-CHEX STAT Streck Laboratories, Inc. | JJY |
| May 2, 1996 | K961293 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 Consolidated Technologies, Inc. | JJY |
| Apr 24, 1996 | K955691 | SERUM VOLATILES CONTROL LEVEL 1 & 2 Clinical Controls, Inc. | JJY |
| Apr 24, 1996 | K955690 | AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 Clinical Controls, Inc. | JJY |
| Apr 23, 1996 | K960824 | IMMUNOLOGY CONTROL Medical Analysis Systems, Inc. | JJY |
| Apr 3, 1996 | K960862 | LIPID CONTROL Medical Analysis Systems, Inc. | JJY |
| Mar 12, 1996 | K955812 | SYSCON TURMOR MARKER CONTROL Scantibodies Laboratory, Inc. | JJY |
| Feb 21, 1996 | K955858 | N/T PROTEIN CONTROL SY/L, M AND H Behring Diagnostics, Inc. | JJY |
| Feb 14, 1996 | K954247 | SYSCON CONTROL ASSAYED & UNASSAYED Scantibodies Laboratory, Inc. | JJY |
| Feb 2, 1996 | K955264 | NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 Nova Biomedical Corp. | JJY |
| Feb 2, 1996 | K955260 | NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION Nova Biomedical Corp. | JJY |
| Feb 2, 1996 | K955252 | NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 Nova Biomedical Corp. | JJY |
| Dec 21, 1995 | K954656 | ROCHE CONTROL SERUM P Roche Diagnostic Systems, Inc. | JJY |
| Dec 21, 1995 | K954655 | ROCHE CONTROL SERUM N Roche Diagnostic Systems, Inc. | JJY |
| Nov 28, 1995 | K955024 | LIQUICHEK ETHANOL/AMMONIA CONTROL Bio-Rad | JJY |
| Nov 9, 1995 | K954323 | MAS LIQUID URINALYSIS CONTROL Medical Analysis Systems, Inc. | JJY |
| Nov 1, 1995 | K954298 | VIROTROL IV Blackhawk Biosystems, Inc. | JJY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.