K832098 is an FDA 510(k) clearance for the N-ACETYLPROCAINAMIDE ASSAY FOR COBAS. This device is classified as a Enzyme Immunoassay, N-acetylprocainamide (Class II - Special Controls, product code LAN).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 44 days after receiving the submission on June 29, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K832098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1983 |
| Decision Date | August 12, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LAN — Enzyme Immunoassay, N-acetylprocainamide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |