510(k) K070005 ยท GJS Test, Time, Prothrombin
HEMOSIL RECOMBIPLASTIN 2G
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Aug 15, 2007 |
| Received | Jan 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2013 | Instrumentation Laboratory Co. HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy. Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.