510(k) K901003 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 16, 1990 |
| Received | Mar 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901003
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2004 | Roche Diagnostics Corp. Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680. Terminated |
JJE | None listed |
| Sep 2, 2004 | Roche Diagnostics Corp. Roche/Hitachi 747 - 200 clinical chemistry analyzer; catalog number 04009223680. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.