K973189 is an FDA 510(k) clearance for the RETINOL BINDING PROTEIN RBP 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 September 29, 1997, 35 days after receiving the submission on August 25, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5765.
| 510(k) Number | K973189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1997 |
| Decision Date | September 29, 1997 |
| Days to Decision | 35 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 |