GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664— 510(k) K884988

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K884988 for GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664, Substantially Equivalent on 1989-01-13. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JQB
Advisory panel: Clinical Chemistry
Date received: 1988-12-01
Decision date: 1989-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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