EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415— 510(k) K924572

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K924572 for EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415, Substantially Equivalent on 1992-11-25. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 1992-09-10
Decision date: 1992-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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