AMYLASE TEST (AMYL) ITEM NUMBER: 65653— 510(k) K884382

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K884382 for AMYLASE TEST (AMYL) ITEM NUMBER: 65653, Substantially Equivalent on 1989-01-11. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIW
Advisory panel: Clinical Chemistry
Date received: 1988-10-18
Decision date: 1989-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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