K000566

Substantially Equivalent

MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LTJ
Advisory panel: Immunology
Date received: 2000-02-22
Decision date: 2000-03-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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