K042479 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS. This device is classified as a Enzyme Immunoassay, Gentamicin (Class II - Special Controls, product code LCD).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 6, 2005, 115 days after receiving the submission on September 13, 2004.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K042479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2004 |
| Decision Date | January 06, 2005 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCD — Enzyme Immunoassay, Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |