510(k) K901086 ยท KLT Enzyme Immunoassay, Carbamazepine
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 30, 1990 |
| Received | Mar 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901086
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.