510(k) K913963 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
IMMUCHEM NEONATAL TSH-MP ELISA
| Applicant | Icn Biomedicals, Inc., Costa Mesa CA, US |
| Decision | Substantially Equivalent, Dec 13, 1991 |
| Received | Sep 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913963
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.