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 4, 1986 | K862278 | GAS-TRAK United Diagnostics, Inc. | JJY |
| Aug 4, 1986 | K862185 | LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL Bio-Rad | JJY |
| Jul 2, 1986 | K860999 | GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED Ciba Corning Diagnostics Corp. | JJY |
| Jul 1, 1986 | K862179 | SOMAS LIQUID URINE CONTROL Somas Medical Industries, Inc. | JJY |
| Jun 17, 1986 | K861901 | MULTI-4 CO-OXIMETER CONTROL Allied Instrumentation Laboratory | JJY |
| May 29, 1986 | K860906 | STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III American Dade | JJY |
| May 23, 1986 | K861603 | IRON PROCEDURE Data Medical Associates, Inc. | JJY |
| May 23, 1986 | K861567 | CONTROL SERA LEVEL VALUES (MG/DL) E.I. Dupont DE Nemours & Co., Inc. | JJY |
| May 23, 1986 | K861185 | THERACHEM-PLUS, TRI-LEVEL TDC (TM) Fisher Scientific Co., LLC | JJY |
| May 23, 1986 | K860942 | QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID Quantimetrix Corp. | JJY |
| Apr 28, 1986 | K861448 | QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID Quantimetrix Medical Industries | JJY |
| Apr 7, 1986 | K861068 | GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED Ciba Corning Diagnostics Corp. | JJY |
| Apr 3, 1986 | K861000 | GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED Ciba Corning Diagnostics Corp. | JJY |
| Apr 3, 1986 | K860998 | GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED Ciba Corning Diagnostics Corp. | JJY |
| Apr 3, 1986 | K860970 | PRECINORM IM AND PRECIPATH IM Boehringer Mannheim Corp. | JJY |
| Mar 17, 1986 | K860355 | BOVINE CHEMISTRY CONTROL I.X AND II.X American Dade | JJY |
| Mar 17, 1986 | K855036 | CHEMISTRY CONTROL N & A Integrated Medical Systems Int'L., Inc. | JJY |
| Mar 17, 1986 | K855035 | CALIBRATION REFERENCE I & II Integrated Medical Systems Int'L., Inc. | JJY |
| Jan 17, 1986 | K854931 | CANTROL ELECTROPHORESIS CONTROL Canyon Diagnostics, Inc. | JJY |
| Jan 13, 1986 | K854789 | RANGE-CHEK American Monitor Corp. | JJY |
| Jan 7, 1986 | K854967 | CRITIC - SF, ASSAYED Dimension Diagnostics | JJY |
| Dec 23, 1985 | K853943 | CRITIC C LEVEL I & II Dimension Diagnostics | JJY |
| Oct 25, 1985 | K854119 | ACCURACY Columbia Diagnostics, Inc. | JJY |
| Oct 4, 1985 | K853931 | QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL Quantimetrix Corp. | JJY |
| Oct 4, 1985 | K853906 | LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) Biodiagnostic Intl | JJY |
| Aug 2, 1985 | K852753 | DC LIQUITROL LEVEL 1 & 2 Diagnostic Chemicals, Ltd. (Usa), CA | JJY |
| Jul 15, 1985 | K852418 | QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL) Amf Biological and Diagnostics Co. | JJY |
| Jul 15, 1985 | K851820 | SPINAL FLUID CONTROL Irvine Scientific | JJY |
| Jul 12, 1985 | K852594 | DC-LIP, CATALOGUE NUMBER SE-020 Diagnostic Chemicals, Ltd. (Usa), CA | JJY |
| May 31, 1985 | K851942 | COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY Coulter Electronics, Inc. | JJY |
| Apr 12, 1985 | K850574 | DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO American Dade | JJY |
| Apr 10, 1985 | K850575 | DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H American Dade | JJY |
| Mar 5, 1985 | K850017 | PRECINORM H & PRECIPATH H Boehringer Mannheim Corp. | JJY |
| Mar 1, 1985 | K844848 | IMA-TROL IMMUNOASSAY CONTROL Dimension Diagnostics | JJY |
| Feb 27, 1985 | K844413 | ULTROSER G Lkb Instruments, Inc. | JJY |
| Feb 6, 1985 | K850202 | GELMAN TRIPHOR CONTROL Gelman Sciences, Inc. | JJY |
| Feb 6, 1985 | K844996 | PARAGON TRICHECK ELECTROPHORESIS CONTROL Beckman Instruments, Inc. | JJY |
| Jan 8, 1985 | K844760 | UROL-QUAL Dimension Diagnostics | JJY |
| Jan 8, 1985 | K844125 | LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN Bio-Rad | JJY |
| Nov 27, 1984 | K844018 | GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 United Diagnostics, Inc. | JJY |
| Nov 27, 1984 | K843986 | STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 United Diagnostics, Inc. | JJY |
| Sep 28, 1984 | K843611 | QUALIFY I & II AMER. MONITOR 2009 & 2010 American Monitor Corp. | JJY |
| Aug 29, 1984 | K842970 | ALLERGENTICS TOTAL IGE/THEOPHYLLINE Allergenetics | JJY |
| Jul 6, 1984 | K841884 | KODAK EKTACHEM CONTROL Eastman Kodak Company | JJY |
| Jun 22, 1984 | K841452 | NOVA STAT CONTROL LEVELS 1/2/3 Nova Biomedical Corp. | JJY |
| Apr 17, 1984 | K840458 | BIOTIS ABNORMAL CLINICAL CHEM SERUM- Otisville Biotech, Inc. | JJY |
| Apr 13, 1984 | K840457 | NORMAL CLINICAL CHEM. CONTROL SERUM- Otisville Biotech, Inc. | JJY |
| Mar 23, 1984 | K834064 | ORTHO BI-LEVEL RECEPTOR CONTROL Ortho Diagnostic Systems, Inc. | JJY |
| Jan 13, 1984 | K833009 | OMNI-FAL I & II American Monitor Corp. | JJY |
| Jan 4, 1984 | K833639 | TITANGEL HIGH RESOLUTION CONTROL Helena Laboratories | JJY |
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