510(k) K936229 ยท CDP Radioimmunoassay, Total Triiodothyronine
AIA-PACK TT3 ASSAY
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Jul 14, 1994 |
| Received | Dec 29, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936229
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2006 | Tosoh Bioscience Inc TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum.
Each box of product contains 5 trays of 20 te Terminated |
CDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.