K002585 is an FDA 510(k) clearance for the RANDOX TRANSFERRIN. This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on February 5, 2001, 168 days after receiving the submission on August 21, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K002585 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2000 |
| Decision Date | February 05, 2001 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |