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FDA 510(k)

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760

K-Number: K031308 · 2003-09-26

ApplicantRhigene, Inc.
Decision Date2003-09-26
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 is the device name listed in this FDA 510(k) record. The listed applicant is Rhigene, Inc.. It received FDA 510(k) clearance on 2003-09-26 under 510(k) number K031308. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760?

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 is a medical device that received FDA 510(k) clearance on 2003-09-26. The listed applicant is Rhigene, Inc.. The 510(k) number is K031308.

When did RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 receive FDA 510(k) clearance?

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 received FDA 510(k) clearance on 2003-09-26, under 510(k) number K031308.

Who is the listed applicant for RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760?

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

What is the FDA product code for RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760?

The FDA product code for RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 is DBM.

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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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