K945125 is an FDA 510(k) clearance for the DUPONT ACA VANCOMYCIN (VANC) METHOD. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by The DU Pont Co. (Wilimington, US). The FDA issued a Cleared decision on March 10, 1995, 142 days after receiving the submission on October 19, 1994.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K945125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1994 |
| Decision Date | March 10, 1995 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |