510(k) K974569 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Dec 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974569
| 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; Catalog number 7745, Part numbers 054207608 and 04393201001. 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 |
| Apr 10, 2003 | Roche Diagnostics Corp. CoaguChek PT test strips, sold in 12 pack. Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.