510(k) K972733 ยท CGA Glucose Oxidase, Glucose
AVL OMNI ANALYZER
| Applicant | Avl Scientific Corp., Roswell GA, US |
| Decision | Substantially Equivalent, Sep 9, 1997 |
| Received | Jul 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Roche Diagnostics Corp. Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R. Terminated |
JJE | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R. Terminated |
JJE | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591. Terminated |
JJE | None listed |
| Jan 10, 2004 | Roche Diagnostics Corp. Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. Terminated |
JJE | None listed |
| Jan 10, 2004 | Roche Diagnostics Corp. Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. Terminated |
JJE | None listed |
| Jan 10, 2004 | Roche Diagnostics Corp. Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.