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FDA 510(k)

RHIGENE HEP-ANA TEST SYSTEM

K-Number: K042680 · 2004-11-19

ApplicantCorgenix, Inc.
Decision Date2004-11-19
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHIGENE HEP-ANA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corgenix, Inc.. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K042680. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHIGENE HEP-ANA TEST SYSTEM?

RHIGENE HEP-ANA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Corgenix, Inc.. The 510(k) number is K042680.

When did RHIGENE HEP-ANA TEST SYSTEM receive FDA 510(k) clearance?

RHIGENE HEP-ANA TEST SYSTEM received FDA 510(k) clearance on 2004-11-19, under 510(k) number K042680.

Who is the listed applicant for RHIGENE HEP-ANA TEST SYSTEM?

The FDA 510(k) record lists Corgenix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RHIGENE HEP-ANA TEST SYSTEM?

The FDA product code for RHIGENE HEP-ANA TEST SYSTEM is DHN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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