K955881 is an FDA 510(k) clearance for the RETINOL BINDING RID KIT. This device is classified as a Retinol-binding Protein, Antigen, Antiserum, Control (Class I - General Controls, product code CZS).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on March 22, 1996, 85 days after receiving the submission on December 28, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5765.
| 510(k) Number | K955881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1995 |
| Decision Date | March 22, 1996 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | CZS — Retinol-binding Protein, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5765 |