Panels › Clinical Chemistry › Product code JJG · Class 1
Analyzer, Chemistry, Centrifugal, For Clinical Use
Regulation 862.2140
0510(k)s in 12 months (30 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JJG
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 4 | 0 |
| Union Carbide Corp. | 4 | 0 |
| Abaxis, Inc. | 2 | 1 |
| American Scientific Products | 2 | 0 |
| Baker Instructions Corp. | 2 | 0 |
| Beckman Instruments, Inc. | 2 | 0 |
| Instrumentation Laboratory CO | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Autogenic Systems | 1 | 0 |
| Clinical Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 1997 | K972409 | AG CHEMISTRY ANALYZER SYSTEM Landmark Scientific, Inc. | JJG |
| Mar 13, 1995 | K942782 | PICCOLO(TM) Abaxis, Inc. | JJG |
| Apr 6, 1994 | K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR Abaxis, Inc. | JJG |
| Jun 10, 1992 | K920942 | OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER Olympus Corp. | JJG |
| Feb 27, 1991 | K910222 | COBAS ALPHA Roche Diagnostic Systems, Inc. | JJG |
| Oct 15, 1990 | K903626 | BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA Beckman Instruments, Inc. | JJG |
| Aug 3, 1989 | K893854 | COBAS FARA II CENTRIFUGAL ANALYZER Roche Diagnostic Systems, Inc. | JJG |
| Jul 20, 1989 | K893641 | COBAS FARA CENTRIFUGAL ANALYZER Roche Diagnostic Systems, Inc. | JJG |
| Mar 28, 1989 | K885203 | TECHNICON DAX(TM) SYSTEM Technicon Instruments Corp. | JJG |
| Jun 11, 1987 | K871973 | IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. Instrumentation Laboratory CO | JJG |
| May 26, 1987 | K871838 | BIOMEK 1000C AUTOMATED LABORATORY WORK STATION Beckman Instruments, Inc. | JJG |
| Jan 8, 1986 | K854523 | ANALYST PHYSICIAN'S OFFICE PROFILER E.I. Dupont DE Nemours & Co., Inc. | JJG |
| Nov 19, 1985 | K854055 | I.C.L.S. COMPULYZER Integrated Computerized Laboratory Systems, Inc. | JJG |
| May 14, 1985 | K851619 | GEN PROFILER SYSTEM Electro-Cucleonics, Inc. | JJG |
| Nov 27, 1984 | K843914 | COBAS FLUORESCENCE POLARIZATION MODULE Roche Diagnostic Systems, Inc. | JJG |
| Aug 2, 1984 | K842522 | PDA SYSTEM Abbott Laboratories | JJG |
| Mar 22, 1984 | K840231 | DISPOSABLE CUVETTE ARRAY Consumable Lab Supplies | JJG |
| Oct 4, 1983 | K832716 | ENCORE CHEMISTRY ANALYZER Baker Instructions Corp. | JJG |
| Jun 30, 1983 | K831571 | ROTOR American Scientific Products | JJG |
| Jun 30, 1983 | K831569 | REAGENT CUPS American Scientific Products | JJG |
| Apr 5, 1983 | K830641 | ENCORE CHEMISTRY ANALYZER Baker Instructions Corp. | JJG |
| Jun 18, 1981 | K811525 | FLEXIGRAM AUTO LOADER SYSTEM Electro-Nucleonics Laboratories, Inc. | JJG |
| Jun 9, 1980 | K801139 | CENTRIFICHEM SYSTEM 500 ANALYZER Union Carbide Corp. | JJG |
| May 28, 1980 | K801026 | IL MODEL 773 FLUORESCENCE LIGHT SCATTER Instrumentation Laboratory CO | JJG |
| Jan 17, 1980 | K792671 | COBAS-BIO CENTRIFUGAL ANALYZER Hoffmann-La Roche, Inc. | JJG |
| Aug 10, 1979 | K791180 | CENTRIFICHEM SYSTEM 500 Union Carbide Corp. | JJG |
| May 7, 1979 | K790550 | CENTRIA SYSTEM Union Carbide Corp. | JJG |
| Apr 4, 1979 | K790278 | ANALYZER, CENTRIFUCHEM SYSTEM 400 Union Carbide Corp. | JJG |
| Dec 20, 1978 | K781900 | ANALYZER, AUTOMED CENTRIFUGAL Autogenic Systems | JJG |
| Oct 25, 1977 | K771813 | CENTRIFICHEM SYS 400 ANALYZER Clinical Diagnostics, Inc. | JJG |
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