510(k) K935049 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
ELEGANCE NEONATAL TSH ELISA
| Applicant | Bioclone Australia Pty , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Oct 3, 1994 |
| Received | Oct 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935049
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.