K984166 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3. This device is classified as a Acid, Folic, Radioimmunoassay (Class II - Special Controls, product code CGN).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 5, 1999, 77 days after receiving the submission on November 20, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K984166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1998 |
| Decision Date | February 05, 1999 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |