VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)— 510(k) K973030

Substantially Equivalent

Johnson & Johnson Clinical Diagnostics, Inc.

FDA 510(k) clearance K973030 for VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300), Substantially Equivalent on 1997-09-04. Applicant: Johnson & Johnson Clinical Diagnostics, Inc..

Clearance details

Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1997-08-14
Decision date: 1997-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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