VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III— 510(k) K043384
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K043384 for VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III, Substantially Equivalent on 2005-02-07. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Product code
- Code LDO
- Device class
- Class 2
- Regulation
- 21 CFR 862.3900
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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