K881040 is an FDA 510(k) clearance for the EMIT VANCOMYCIN ASSAY. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on April 19, 1988, 39 days after receiving the submission on March 11, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K881040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1988 |
| Decision Date | April 19, 1988 |
| Days to Decision | 39 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 |