510(k) K972586 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
AIA-PACK TSH 3RD-GEN ASSAY
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Aug 29, 1997 |
| Received | Jul 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc AIA-PACK TSH 3rd Generation; Part Number: 020294
Assay, Thyroid Terminated |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.