510(k) K964506 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
ROCHE COBAS AMPLICOR ANALYZER
| Applicant | Roche Molecular Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, May 21, 1997 |
| Received | Nov 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964506
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2007 | Roche Molecular Systems, Inc. Amplilink Software versions 1.1, 1.3, 1.4, 2.41.
COBAS Amplicor CTA & NGA Tests Terminated |
JJF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.