510(k) K964349 ยท CGN Acid, Folic, Radioimmunoassay
AIA-PACK FOLATE ASSAY
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Nov 27, 1996 |
| Received | Oct 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964349
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2018 | Tosoh Bioscience Inc AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers. Terminated |
CGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.