510(k) K001606 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
| Applicant | Repromedix Corp., Woburn MA, US |
| Decision | Substantially Equivalent, Oct 5, 2000 |
| Received | May 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001606
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.