REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139— 510(k) K032868

Name: FDA 510(k) clearance K032868
Creator: U.S. Food and Drug Administration
Published: 2003-10-14

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K032868 for REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139, Substantially Equivalent on 2003-10-14. Applicant: Corgenix, Inc.. Device class: 2.

Clearance details

Applicant: Corgenix, Inc.
Product code: Code MID
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2003-09-15
Decision date: 2003-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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