K811770 is an FDA 510(k) clearance for the EMIT-CAD PROCAINAMIDE ASSAY. This device is classified as a Enzyme Immunoassay, Procainamide (Class II - Special Controls, product code LAR).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981, 18 days after receiving the submission on June 22, 1981.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K811770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1981 |
| Decision Date | July 10, 1981 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LAR — Enzyme Immunoassay, Procainamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |