K861512

Substantially Equivalent

EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95

Applicant: Em Diagnostic Systems, Inc.
Product code: JJT
Advisory panel: Clinical Chemistry
Date received: 1986-04-23
Decision date: 1986-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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