REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT— 510(k) K001352

Name: FDA 510(k) clearance K001352
Creator: U.S. Food and Drug Administration
Published: 2001-04-09

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K001352 for REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT, Substantially Equivalent on 2001-04-09. Applicant: Corgenix, Inc.. Device class: 2.

Clearance details

Applicant: Corgenix, Inc.
Product code: Code DHC
Device class: Class 2
Regulation: 21 CFR 866.5820
Advisory panel: Immunology
Date received: 2000-04-28
Decision date: 2001-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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