DeviceClearance

VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2— 510(k) K012593

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K012593 for VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2, Substantially Equivalent on 2001-08-30. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

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