510(k) K012966 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
ROCHE COBAS TAQMAN ANALYZER
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Feb 1, 2002 |
| Received | Sep 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2004 | Roche Molecular Systems Inc COBAS TaqMan Analyzer Terminated |
JJF | None listed |
| Jul 27, 2004 | Roche Molecular Systems Inc COBAS TaqMan 48 Analyzers. Terminated |
JJF | None listed |
| Jun 5, 2003 | Roche Molecular Systems Inc COBAS TaqMan analyzer, Series 96; catalog number 8080216. Terminated |
JJF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.