Submission Details
| 510(k) Number | K042479 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE
Jan 2005
Decision
115d
Days
Class 2
Risk
About This 510(k) Submission
K042479 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE, 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 review panel. Regulated under 21 CFR 862.3450.
Device Classification
| Product Code | LCD — Enzyme Immunoassay, Gentamicin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3450 |
Manufacturer
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