K042494 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III. This device is classified as a Complement C3, Antigen, Antiserum, Control (Class II - Special Controls, product code CZW).
Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 19, 2004, 35 days after receiving the submission on September 14, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K042494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2004 |
| Decision Date | October 19, 2004 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CZW — Complement C3, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |