510(k) K984321 ยท CDD Radioassay, Vitamin B12
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 22, 1999 |
| Received | Dec 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2018 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489
For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA Terminated |
CDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.