JTL
12 FDA 510(k) clearances · Product code
31 daysmedian time to decision
90 days90th percentile
12clearances measured
FDA profile
- Official device name
- Plasma, Coagulase, Human, Horse And Rabbit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2160
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2002: 2 · 2003: 12 · 2004: 3 · 2005: 11 · 2006: 2
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 |
|---|---|---|
| DRYSLIDE COAGULASE (K950706) | Difco Laboratories, Inc. | 1995-05-16 |
| RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (K883333) | Immuno-Mycologics, Inc. | 1988-08-25 |
| RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 (K870945) | Oxoid U.S.A., Inc. | 1987-06-10 |
| LYFO-KWIK (TM) COAGULASE PLASMA (K861312) | Micro-Bio-Logics | 1986-04-18 |
| HEMASTAPH (K840553) | Remel Co. | 1984-04-13 |
| API STAPHASE III (K833988) | Analytical Products, Inc. | 1983-12-22 |
| COAGULASE PLASMA, HORSE & RABBIT EDTA (K833858) | Otisville Biotech, Inc. | 1983-12-08 |
| COAGULASE PLASMA-CITRATED & EDTA (K822988) | American Scientific Products | 1982-11-05 |
| COAGULASE PLASMA (K820177) | Quadroma, Inc. | 1982-02-05 |
| RABBIT COAGULASE PLASMA (K812602) | Dutchland Laboratories, Inc. | 1981-09-29 |
| STAPHASE* (K811982) | Analytical Products, Inc. | 1981-07-28 |
| COAGULASE PLASMA (K792235) | Remel Co. | 1979-12-07 |
Track JTL automatically
Every clearance here is in the API, with alerts when new ones post.