TOTAL IRON UIBC/TIBC ASSAY— 510(k) K840485

Name: FDA 510(k) clearance K840485
Creator: U.S. Food and Drug Administration
Published: 1984-03-12

Substantially Equivalent

Somas Medical Industries, Inc.

FDA 510(k) clearance K840485 for TOTAL IRON UIBC/TIBC ASSAY, Substantially Equivalent on 1984-03-12. Applicant: Somas Medical Industries, Inc.. Device class: 1.

Clearance details

Applicant: Somas Medical Industries, Inc.
Product code: Code CFM
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1984-02-06
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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