510(k) K912241 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Jun 20, 1991 |
| Received | May 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912241
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.