510(k) K060770— VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: 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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