K914464

Substantially Equivalent

ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43

Applicant: Em Diagnostic Systems, Inc.
Product code: CKA
Advisory panel: Clinical Chemistry
Date received: 1991-10-07
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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