REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT— 510(k) K983914

Name: FDA 510(k) clearance K983914
Creator: U.S. Food and Drug Administration
Published: 1998-12-22

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K983914 for REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT, Substantially Equivalent on 1998-12-22. Applicant: Corgenix, Inc.. Device class: 2.

Clearance details

Applicant: Corgenix, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1998-11-04
Decision date: 1998-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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