510(k) K964982— VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)

Substantially Equivalent

Johnson & Johnson Clinical Diagnostics, Inc.

Clearance details

Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
Product code: Code CEP
Advisory panel: Clinical Chemistry
Date received: 1996-12-12
Decision date: 1997-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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