510(k) K062581 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Nov 29, 2006 |
| Received | Aug 31, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062581
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.