K823128 is an FDA 510(k) clearance for the ADVANCE 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 November 29, 1982, 35 days after receiving the submission on October 25, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K823128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1982 |
| Decision Date | November 29, 1982 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LAR — Enzyme Immunoassay, Procainamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |