K902483

Substantially Equivalent

CREATINE KINASE-MB TEST (MB-DS) ITEM #67655

Applicant: Em Diagnostic Systems, Inc.
Product code: CGS
Advisory panel: Clinical Chemistry
Date received: 1990-06-05
Decision date: 1990-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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