510(k) K951321 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Aug 24, 1995 |
| Received | Mar 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951321
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.