510(k) K913493 ยท CEC Radioimmunoassay, Free Thyroxine
AIA-PACK FT4
| Applicant | Tosoh Corp., Washington, D.C. DC, US |
| Decision | Substantially Equivalent, Sep 10, 1991 |
| Received | Aug 6, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK FT4; Part Number: 025268
Assay, Thyroid Terminated |
CEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.