K822588 is an FDA 510(k) clearance for the ADVANCE EMIT-CAD QUINIDINE ASSAY. This device is classified as a Enzyme Immunoassay, Quinidine (Class II - Special Controls, product code LBZ).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1982, 22 days after receiving the submission on August 26, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K822588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1982 |
| Decision Date | September 17, 1982 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LBZ — Enzyme Immunoassay, Quinidine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |