ABBOTT QLUICKSTART IRON TEST, ITEM #5A29— 510(k) K913705

Name: FDA 510(k) clearance K913705
Creator: U.S. Food and Drug Administration
Published: 1991-10-09

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K913705 for ABBOTT QLUICKSTART IRON TEST, ITEM #5A29, Substantially Equivalent on 1991-10-09. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CFM
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1991-08-19
Decision date: 1991-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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