REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT— 510(k) K024196

Name: FDA 510(k) clearance K024196
Creator: U.S. Food and Drug Administration
Published: 2003-01-03

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K024196 for REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT, Substantially Equivalent on 2003-01-03. 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: 2002-12-20
Decision date: 2003-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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