510(k) K915194 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
CEDIA T4
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 9, 1991 |
| Received | Nov 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915194
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.