510(k) K925604 ยท GJS Test, Time, Prothrombin
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Mar 12, 1993 |
| Received | Nov 5, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2006 | Instrumentation Laboratory Co. Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 vials of Hemoliance RecombiPlasTin matched with 25 vials of Hemoliance RecombiPlasTin Diluent. Hemoliance Reco Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.