EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95— 510(k) K860935

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K860935 for EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95, Substantially Equivalent on 1986-05-23. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIJ
Advisory panel: Clinical Chemistry
Date received: 1986-03-12
Decision date: 1986-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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