K970643

Substantially Equivalent

VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)

Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
Product code: CHP
Advisory panel: Clinical Chemistry
Date received: 1997-02-20
Decision date: 1997-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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