K821413 is an FDA 510(k) clearance for the EMIT C-REACTIVE PROTEIN ASSAY. This device is classified as a System, Test, C-reactive Protein (Class II - Special Controls, product code DCN).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982, 16 days after receiving the submission on May 12, 1982.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5270.
| 510(k) Number | K821413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1982 |
| Decision Date | May 28, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DCN — System, Test, C-reactive Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5270 |