Panels › Clinical Chemistry › Product code JJF · Class 1
Analyzer, Chemistry, Micro, For Clinical Use
Regulation 862.2170
0510(k)s in 12 months (57 all time)
0recalls in 12 months (13 all time)
10recalls that name a 510(k)
Top companies in JJF
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 2 | 5 |
| Vital Scientific N.V. | 1 | 6 |
| Beckman Instruments, Inc. | 3 | 0 |
| Kone Instruments, Inc. | 3 | 0 |
| Syva Co. | 3 | 0 |
| Technicon Instruments Corp. | 3 | 0 |
| Alpkem Corp. | 2 | 0 |
| Associated Electro-Medical Services, Inc. | 2 | 0 |
| Hi Chem, Inc. | 2 | 0 |
| Instrumentation Laboratory CO | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2006 | K052794 | ETI-MAX 3000 DiaSorin, Inc. | JJF |
| Jun 16, 2004 | K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER Arkray, Inc. | JJF |
| Dec 17, 2003 | K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 Roche Diagnostics Corp. | JJF |
| Jun 5, 2002 | K013654 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER Precision Systems, Inc. | JJF |
| Feb 1, 2002 | K012966 | ROCHE COBAS TAQMAN ANALYZER Roche Molecular Systems, Inc. | JJF |
| Dec 2, 1999 | K993634 | CARESIDE ANALYZER Careside, Inc. | JJF |
| Mar 13, 1998 | K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA Vital Scientific N.V. | JJF |
| Mar 6, 1998 | K980056 | CARESIDE ANALYZER Exigent Diagnostics, Inc. | JJF |
| Oct 9, 1997 | K973177 | MAGO AUTOMATED EIA PROCESSOR Diamedix Corp. | JJF |
| Jun 26, 1997 | K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER Synermed, Inc., CA | JJF |
| May 21, 1997 | K964506 | ROCHE COBAS AMPLICOR ANALYZER Roche Molecular Systems, Inc. | JJF |
| May 9, 1997 | K965103 | WINMAX SOFTWARE SYSTEMS Diagnostic Products Corp. | JJF |
| Jan 22, 1997 | K964409 | HCL - 200 BIOCHEMISTRY ANALYZER Hcl Laboratory Systems, Inc. | JJF |
| Dec 24, 1996 | K961209 | BRIO AUTOMATIC SAMPLINC UNIT Seac S.R.L. | JJF |
| May 2, 1995 | K943978 | WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS Waters Chromatography Division | JJF |
| Nov 2, 1994 | K942676 | SYNCHRON CX3 DELTA Beckman-Diagnostic Systems Group | JJF |
| Nov 16, 1993 | K925093 | SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA Beckman Instruments, Inc. | JJF |
| Jun 10, 1991 | K912055 | SYVA EDMS Syva Co. | JJF |
| Sep 27, 1990 | K903357 | SYVA(R) ETS(R) PLUS SYSTEM Syva Co. | JJF |
| Aug 15, 1989 | K893768 | MODIFIED PK300 AUTOMATIC EIA ANALYZER Olympus Corp. | JJF |
| Mar 16, 1989 | K883350 | RECONDITIONED ASTRA(TM) 4 Associated Electro-Medical Services, Inc. | JJF |
| Mar 16, 1989 | K883298 | RECONDITIONED ASTRA (TM) 8 Associated Electro-Medical Services, Inc. | JJF |
| Sep 2, 1988 | K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER Alpkem Corp. | JJF |
| Oct 28, 1987 | K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER Miles Laboratories, Inc. | JJF |
| May 8, 1987 | K871486 | (FPIA) ASSAY BUFFER Windsor Laboratories, Inc. | JJF |
| Mar 13, 1987 | K870777 | PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER Kone Instruments, Inc. | JJF |
| Mar 13, 1987 | K863245 | SYVA ETS SYSTEM Syva Co. | JJF |
| Feb 20, 1987 | K864834 | OLYMPUS PK300 Olympus Corp. | JJF |
| Dec 31, 1986 | K864236 | SYNCHRON CX3 Beckman Instruments, Inc. | JJF |
| Jul 12, 1985 | K852385 | HYBRITECH IMMUNOCHEMISTRY ANALYZER Hybritech, Inc. | JJF |
| Jun 10, 1985 | K851933 | CLINICAL CHEMISTRY ANALYTICAL SYSTEM Allied Instrumentation Laboratory | JJF |
| May 10, 1985 | K851542 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER Alpkem Corp. | JJF |
| May 2, 1985 | K851172 | COBAS MIRA Roche Diagnostic Systems, Inc. | JJF |
| Apr 8, 1985 | K850999 | TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN Technicon Instruments Corp. | JJF |
| Dec 11, 1984 | K844586 | IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS Instrumentation Laboratory CO | JJF |
| Apr 4, 1984 | K840200 | PROGRESS SELECTIVE DHEMISTRY ANALYZ Kone Instruments, Inc. | JJF |
| Jan 30, 1984 | K833998 | QCA CHEMISTRY ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic | JJF |
| Jan 13, 1984 | K833804 | SHABAN 9865 IL#78637 JUNCTION BLOC Shaban Mfg. Co. | JJF |
| Dec 8, 1983 | K833154 | NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM Nova Biomedical Corp. | JJF |
| Nov 25, 1983 | K833153 | NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU Nova Biomedical Corp. | JJF |
| Jun 2, 1983 | K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- Worthington Diagnostic Systems | JJF |
| Jan 28, 1983 | K830095 | RAPID CHEM ANALYZER II Macomb Chemical Co. | JJF |
| Jun 24, 1982 | K821583 | AMES/GILFORD OPTIMATE CLIN. CHEM & THER Gilford Instrument Laboratories, Inc. | JJF |
| May 24, 1982 | K820541 | MICROLYTE Kone Instruments, Inc. | JJF |
| Apr 6, 1982 | K820748 | POLI-MAK MODEL F-4 (FINAL Pm America, Inc. | JJF |
| Mar 11, 1982 | K820415 | 4150 ALPHA AMINO ACID ANALYZER Lkb Instruments, Inc. | JJF |
| Dec 22, 1980 | K803004 | AMINO ACID ANALYSER SYSTEM Lkb Instruments, Inc. | JJF |
| Oct 31, 1980 | K802398 | ELECTROLY TE CHEMISTRY ANALYZER Instrumentation Laboratory CO | JJF |
| Oct 31, 1980 | K802264 | WASH SOLUTION KIT, #88102 Hi Chem, Inc. | JJF |
| Oct 23, 1980 | K802392 | ASTRA PRINTER PAPER #88112-CHLORIDE SILV Hi Chem, Inc. | JJF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.