VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V— 510(k) K062637
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K062637 for VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V, Substantially Equivalent on 2006-11-22. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code DJR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3620
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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