CHOLESTEROL (CHOL) TEST ITEM NO. 65410— 510(k) K935136

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K935136 for CHOLESTEROL (CHOL) TEST ITEM NO. 65410, Substantially Equivalent on 1993-12-16. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CHH
Advisory panel: Clinical Chemistry
Date received: 1993-10-28
Decision date: 1993-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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