REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT— 510(k) K013018

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K013018 for REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT, Substantially Equivalent on 2001-09-20. Applicant: Corgenix, Inc..

Clearance details

Applicant: Corgenix, Inc.
Product code: Code MID
Advisory panel: Immunology
Date received: 2001-09-07
Decision date: 2001-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Westminster, CO, US

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