DeviceClearance

VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III— 510(k) K043384

Substantially Equivalent

Ortho-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..

Clearance details

Applicant
Ortho-Clinical Diagnostics, Inc.
Product code
Code LDO
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rochester, NY, US
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