510(k) K984321— VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 1998-12-03
Decision date: 1999-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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