AMYLASE TEST— 510(k) K923677

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K923677 for AMYLASE TEST, Substantially Equivalent on 1992-09-09. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1992-07-22
Decision date: 1992-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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