510(k) K942884 ยท GJS Test, Time, Prothrombin
COAGUCHEK SYSTEM
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 11, 1995 |
| Received | Jun 17, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942884
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2005 | Roche Diagnostics Corp. Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001. Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.