510(k) K983892 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
| Applicant | Roche Diagnostics/Boehringer Mannheim GmbH, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 13, 1999 |
| Received | Nov 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2003 | Roche Diagnostics Corp. CoaguChek Pro DM meter; catalog # 1894048 and 1893211. Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.