K001636 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN ANTISERUM KIT. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on August 24, 2000, 86 days after receiving the submission on May 30, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K001636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2000 |
| Decision Date | August 24, 2000 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |