IRON-PC-SL ASSAY MODEL # 151-10, 151-26— 510(k) K020816

Name: FDA 510(k) clearance K020816
Creator: U.S. Food and Drug Administration
Published: 2002-05-14

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K020816 for IRON-PC-SL ASSAY MODEL # 151-10, 151-26, Substantially Equivalent on 2002-05-14. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 2002-03-13
Decision date: 2002-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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