JSP
18 FDA 510(k) clearances · Product code
69 daysmedian time to decision
188 days90th percentile
18clearances measured
FDA profile
- Official device name
- Kit, Anaerobic Identification
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1992: 1 · 2015: 14 · 2016: 13 · 2017: 23
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 |
|---|---|---|
| LYFO(TM) DIFFERENTIAL DISK (K945488) | Microbiologics, Inc. | 1995-05-11 |
| LYFO(TM) DIFFERENTIAL DISK (K945489) | Microbiologics, Inc. | 1995-05-11 |
| LYFO(TM) DIFFERENTIAL DISK (K945487) | Microbiologics, Inc. | 1995-05-11 |
| BBLCRYSTAL ANAEROBE ID SYSTEM (K944528) | Becton Dickinson Microbiology Systems | 1995-03-07 |
| VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION (K910666) | Vitek Systems, Inc. | 1991-04-03 |
| VITEK ANAEROBE IDENTIFICATION CARD (K900996) | Vitek Systems, Inc. | 1990-05-11 |
| B. FRAGTEX (K881380) | American Biomedical Products, Inc. | 1988-10-06 |
| IDS RAPID ANA SYSTEM (K882960) | Innovative Diagnostic Systems, Inc. | 1988-08-12 |
| DIAGNOSTIC REAGENT PET-RPLA (K855235) | Oxoid U.S.A., Inc. | 1986-11-04 |
| ANAEROBE RAPID CHROMOGENIC ID PANEL (K862332) | American Micro Scan | 1986-08-27 |
| ANAEROBE KIT (K850052) | Austin Biological Laboratories | 1985-03-05 |
| AMS ANA CARD (K843686) | Vitek Systems, Inc. | 1984-12-12 |
| API ANAIDENT (K831032) | Analytical Products, Inc. | 1983-05-05 |
| ANAEROBE MIC/ID TEMPLATE, & TAXONOMY (K830964) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-05-04 |
| IDA RAPID O2A SYSTEM (K820483) | Innovative Diagnostic Systems, Inc. | 1982-03-15 |
| ANAIROBE-TEK (K802626) | Flow Laboratories, Inc. | 1980-11-12 |
| TEST PANEL FOR PRESUMP. ID/BACT. ORG (K801547) | Micro-Media Systems, Inc. | 1980-09-09 |
| API 20A (K771616) | Analytical Products, Inc. | 1977-09-02 |
Track JSP automatically
Every clearance here is in the API, with alerts when new ones post.