510(k) K980574 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
| Applicant | Alfa Biotech (Uk) , Ltd., Aldershot, GB |
| Decision | Substantially Equivalent, Mar 24, 1998 |
| Received | Feb 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980574
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.