RHIGENE HEP-ANA TEST SYSTEM— 510(k) K042680

Substantially Equivalent

Corgenix, Inc.

FDA 510(k) clearance K042680 for RHIGENE HEP-ANA TEST SYSTEM, Substantially Equivalent on 2004-11-19. Applicant: Corgenix, Inc..

Clearance details

Applicant: Corgenix, Inc.
Product code: Code DHN
Advisory panel: Immunology
Date received: 2004-09-29
Decision date: 2004-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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