510(k) K912852 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Sep 27, 1991 |
| Received | Jun 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912852
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.