K801204 is an FDA 510(k) clearance for the EMIT 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 June 9, 1980, 21 days after receiving the submission on May 19, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3555.
| 510(k) Number | K801204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1980 |
| Decision Date | June 09, 1980 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KLR — Enzyme Immunoassay, Lidocaine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3555 |