510(k) K954018 ยท GKR System, Hemoglobin, Automated
AVL OMNI ANALYZER
| Applicant | Avl Scientific Corp., Roswell GA, US |
| Decision | Substantially Equivalent, Oct 5, 1995 |
| Received | Aug 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954018
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Roche Diagnostics Corp. Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R. Terminated |
JJE | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591. Terminated |
JJE | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R . Terminated |
JJE | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R. Terminated |
JJE | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591. Terminated |
JJE | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.