EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019— 510(k) K874705

Name: FDA 510(k) clearance K874705
Creator: U.S. Food and Drug Administration
Published: 1987-12-22

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K874705 for EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019, Substantially Equivalent on 1987-12-22. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JEJ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 1987-11-19
Decision date: 1987-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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