510(k) K964348 ยท CDD Radioassay, Vitamin B12
AIA-PACK B12 ASSAY
| Applicant | Tosoh Medics, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Jan 13, 1997 |
| Received | Oct 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964348
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2019 | Tosoh Smd Inc AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706 Terminated |
CDD | None listed |
| Nov 30, 2018 | Tosoh Bioscience Inc AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers. Terminated |
CDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.