K822308 is an FDA 510(k) clearance for the VANCOMYCIN FLUORESCENT IMMUNOASSAY. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982, 13 days after receiving the submission on August 3, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K822308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1982 |
| Decision Date | August 16, 1982 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |