510(k) K992365 ยท CGN Acid, Folic, Radioimmunoassay
AIA-PACK FOLATE ASSAY
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Aug 10, 1999 |
| Received | Jul 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992365
| 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 |
| Oct 28, 2006 | Tosoh Bioscience Inc TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box. Terminated |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.