K821815 is an FDA 510(k) clearance for the ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY..
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982, 7 days after receiving the submission on June 18, 1982.
This device falls under the Immunology FDA review panel.
| 510(k) Number | K821815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1982 |
| Decision Date | June 25, 1982 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | — |
| Device Class | — |