DeviceClearance

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS— 510(k) K013899

Substantially Equivalent

Ortho-Clinical Diagnostics

FDA 510(k) clearance K013899 for VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS, Substantially Equivalent on 2002-01-24. Applicant: Ortho-Clinical Diagnostics.

Clearance details

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