JTL — Plasma, Coagulase, Human, Horse And Rabbit Class I
FDA product code JTL covers "Plasma, Coagulase, Human, Horse And Rabbit", a Class I medical device regulated under 21 CFR 866.2160. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JTL
- Device Class
- Class I
- Regulation Number
- 866.2160
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950706 | difco laboratories | DRYSLIDE COAGULASE | May 16, 1995 |
| K883333 | immuno-mycologics | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | August 25, 1988 |
| K870945 | oxoid u.s.a | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | June 10, 1987 |
| K861312 | micro-bio-logics | LYFO-KWIK (TM) COAGULASE PLASMA | April 18, 1986 |
| K840553 | remel | HEMASTAPH | April 13, 1984 |
| K833988 | analytical products | API STAPHASE III | December 22, 1983 |
| K833858 | otisville biotech | COAGULASE PLASMA, HORSE & RABBIT EDTA | December 8, 1983 |
| K822988 | american scientific products | COAGULASE PLASMA-CITRATED & EDTA | November 5, 1982 |
| K820177 | quadroma | COAGULASE PLASMA | February 5, 1982 |
| K812602 | dutchland laboratories | RABBIT COAGULASE PLASMA | September 29, 1981 |
| K811982 | analytical products | STAPHASE* | July 28, 1981 |
| K792235 | remel | COAGULASE PLASMA | December 7, 1979 |