K823127 is an FDA 510(k) clearance for the ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL. This device is classified as a N-acetylprocainamide Control Materials (Class I - General Controls, product code LAZ).
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 Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K823127 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 | Toxicology (TX) |
| Summary | — |
| Product Code | LAZ — N-acetylprocainamide Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |