K013899 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on January 24, 2002, 62 days after receiving the submission on November 23, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K013899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2001 |
| Decision Date | January 24, 2002 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | CDD — Radioassay, Vitamin B12 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |