EASY-TEST POTASSIUM K ITEM NUMBER 19XXX— 510(k) K880339

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K880339 for EASY-TEST POTASSIUM K ITEM NUMBER 19XXX, Substantially Equivalent on 1988-02-25. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CEJ
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1988-01-26
Decision date: 1988-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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