K955851 is an FDA 510(k) clearance for the AXSYM VANCOMYCIN II. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 9, 1996, 134 days after receiving the submission on December 27, 1995.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K955851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1995 |
| Decision Date | May 09, 1996 |
| Days to Decision | 134 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 |