510(k) K991252 ยท CDP Radioimmunoassay, Total Triiodothyronine
AIA-PACK FT3 ASSAY
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, May 11, 1999 |
| Received | Apr 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991252
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2018 | Tosoh Bioscience Inc ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specif Terminated |
CDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.