EASY-TEST HEMOGLOBIN (HGB) ITEM #16685— 510(k) K872653

Name: FDA 510(k) clearance K872653
Creator: U.S. Food and Drug Administration
Published: 1987-07-23

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K872653 for EASY-TEST HEMOGLOBIN (HGB) ITEM #16685, Substantially Equivalent on 1987-07-23. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1987-07-07
Decision date: 1987-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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