K823887 is an FDA 510(k) clearance for the ADVANCE EMIT CAD DISOPYRAMIDE ASSAY. This device is classified as a Enzyme Immunoassay, Lidocaine (Class II - Special Controls, product code KLR).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983, 32 days after receiving the submission on December 27, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3555.
| 510(k) Number | K823887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1982 |
| Decision Date | January 28, 1983 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KLR — Enzyme Immunoassay, Lidocaine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3555 |