SYSTEMATE(TM) IRON ITEM NUMBER: 65417— 510(k) K895249

Name: FDA 510(k) clearance K895249
Creator: U.S. Food and Drug Administration
Published: 1989-10-31

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K895249 for SYSTEMATE(TM) IRON ITEM NUMBER: 65417, Substantially Equivalent on 1989-10-31. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1989-08-21
Decision date: 1989-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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