510(k) K915195 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
ENZYMUN-TEST TSH
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 14, 1992 |
| Received | Nov 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915195
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.