510(k) K962571 ยท GJS Test, Time, Prothrombin
COAGUCHEK PST SYSTEM
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 22, 1997 |
| Received | Jul 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2007 | Roche Diagnostics Corp. CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use). Terminated |
GJS | None listed |
| Nov 30, 2006 | Roche Diagnostics Corp. CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per bo Terminated |
GJS | None listed |
| 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 |
| Oct 15, 2003 | Roche Diagnostics Corp. CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strip Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.