K822067 is an FDA 510(k) clearance for the EMIT C-REACTIVE PROTEIN AUTOCAROUSEL. 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 27, 1982, 13 days after receiving the submission on July 14, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K822067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1982 |
| Decision Date | July 27, 1982 |
| Days to Decision | 13 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 |