K874438 is an FDA 510(k) clearance for the STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY. This device is classified as a Radioimmunoassay, Vancomycin (Class II - Special Controls, product code LEH).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on January 21, 1988, 85 days after receiving the submission on October 28, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3950.
| 510(k) Number | K874438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1987 |
| Decision Date | January 21, 1988 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LEH — Radioimmunoassay, Vancomycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3950 |