Panels › Clinical Chemistry › Product code JJI · Class 1
Analyzer, Enzyme, For Clinical Use
Regulation 862.2500
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in JJI
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 2 | 0 |
| Bio-Rad | 2 | 0 |
| Abbott Laboratories MPG | 0 | 1 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Biokinetix Corp. | 1 | 0 |
| Gilford Instrument Laboratories, Inc. | 1 | 0 |
| Olympus Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 1997 | K972024 | CODA AUTOMATED EIA ANALYZER Bio-Rad | JJI |
| Dec 19, 1994 | K944731 | ABBOTT IMX 2 ANALYZER Abbott Laboratories | JJI |
| Jun 16, 1993 | K931970 | ABBOTT IMX2 ANALYER Abbott Laboratories | JJI |
| Apr 21, 1993 | K930898 | RADIAS AUTOMATED IMMUNOASSAY SYSTEM Bio-Rad | JJI |
| Feb 22, 1979 | K790073 | ANALYZER, IMPACT 100 Gilford Instrument Laboratories, Inc. | JJI |
| Aug 14, 1978 | K780972 | QUICKRATE REACTION RATE ANALYZER Olympus Corp. | JJI |
| Sep 20, 1977 | K771591 | MINISTAT-S CHEMISTRY ANALYZER Biokinetix Corp. | JJI |
| Apr 26, 1977 | K770401 | LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE Bd Becton Dickinson Vacutainer Systems Preanalytic | JJI |
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