AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95— 510(k) K870143

Name: FDA 510(k) clearance K870143
Creator: U.S. Food and Drug Administration
Published: 1987-02-11

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K870143 for AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95, Substantially Equivalent on 1987-02-11. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JIF
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 1987-01-13
Decision date: 1987-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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