510(k) K030845 ยท GJS Test, Time, Prothrombin
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 22, 2003 |
| Received | Mar 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2005 | Roche Diagnostics Corp. Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003. Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.