510(k) K043184 ยท GJS Test, Time, Prothrombin
HEMOSIL RECOMBIPLASTIN
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Dec 22, 2004 |
| Received | Nov 17, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043184
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2006 | Instrumentation Laboratory Co. HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipi Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.