K951059 is an FDA 510(k) clearance for the CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on June 19, 1995, 104 days after receiving the submission on March 7, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K951059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1995 |
| Decision Date | June 19, 1995 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |