SYSTEMATE GLUCOSE 67216— 510(k) K843150

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K843150 for SYSTEMATE GLUCOSE 67216, Substantially Equivalent on 1984-08-27. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 1984-08-10
Decision date: 1984-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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