JJI
8 FDA 510(k) clearances · Product code
58 daysmedian time to decision
98 days90th percentile
8clearances measured
FDA profile
- Official device name
- Analyzer, Enzyme, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2500
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CODA AUTOMATED EIA ANALYZER (K972024) | Bio-Rad | 1997-07-30 |
| ABBOTT IMX 2 ANALYZER (K944731) | Abbott Laboratories | 1994-12-19 |
| ABBOTT IMX2 ANALYER (K931970) | Abbott Laboratories | 1993-06-16 |
| RADIAS AUTOMATED IMMUNOASSAY SYSTEM (K930898) | Bio-Rad | 1993-04-21 |
| ANALYZER, IMPACT 100 (K790073) | Gilford Instrument Laboratories, Inc. | 1979-02-22 |
| QUICKRATE REACTION RATE ANALYZER (K780972) | Olympus Corp. | 1978-08-14 |
| MINISTAT-S CHEMISTRY ANALYZER (K771591) | Biokinetix Corp. | 1977-09-20 |
| LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE (K770401) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 |
Track JJI automatically
Every clearance here is in the API, with alerts when new ones post.