510(k) K972133— VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)

Substantially Equivalent

Johnson & Johnson Clinical Diagnostics, Inc.

Clearance details

Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
Product code: Code JLS
Advisory panel: Clinical Chemistry
Date received: 1997-06-06
Decision date: 1997-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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