AMYLASE TEST (AML) ITEM NUMBER: 65404— 510(k) K893751

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K893751 for AMYLASE TEST (AML) ITEM NUMBER: 65404, Substantially Equivalent on 1989-08-17. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 1989-05-19
Decision date: 1989-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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