510(k) K870246 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
REFLOTRON(R) AST (GOT)
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 18, 1987 |
| Received | Jan 21, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870246
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2004 | Roche Diagnostics Corp. Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120. Terminated |
CKD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.