K822347 is an FDA 510(k) clearance for the LIDOCAINE FLUORESCENT IMMUNOASSAY. This device is classified as a Enzyme Immunoassay, Lidocaine (Class II - Special Controls, product code KLR).
Submitted by American Diagnostic Corp. (Walker, US). The FDA issued a Cleared decision on August 25, 1982, 19 days after receiving the submission on August 6, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3555.
| 510(k) Number | K822347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1982 |
| Decision Date | August 25, 1982 |
| Days to Decision | 19 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 |