510(k) K013899 ยท CDD Radioassay, Vitamin B12
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Jan 24, 2002 |
| Received | Nov 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013899
| 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 |
| Feb 21, 2003 | Ortho-Clinical Diagnostics CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 **** Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.