K060770

Substantially Equivalent

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LOL
Advisory panel: Microbiology
Date received: 2006-03-22
Decision date: 2006-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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