K011662 is an FDA 510(k) clearance for the MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL. This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on July 30, 2001, 62 days after receiving the submission on May 29, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K011662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2001 |
| Decision Date | July 30, 2001 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |