510(k) K994349 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
COAGUCHEK S SYSTEM, MODEL 2138280
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 6, 2000 |
| Received | Dec 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994349
| 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 S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001. Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.