K821412 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN CONTROL. This device is classified as a C-reactive Protein, Antigen, Antiserum, And Control (Class II - Special Controls, product code DCK).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982, 71 days after receiving the submission on May 12, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K821412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1982 |
| Decision Date | July 22, 1982 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |