510(k) K935399 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Dec 19, 1994 |
| Received | Nov 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935399
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.