K042477 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TRFRN REAHENT. This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on November 19, 2004, 67 days after receiving the submission on September 13, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K042477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2004 |
| Decision Date | November 19, 2004 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |