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FDA 510(k)

MESACUP TEST PR-3

K-Number: K040711 · 2004-04-02

ApplicantRhigene, Inc.
Decision Date2004-04-02
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MESACUP TEST PR-3 is the device name listed in this FDA 510(k) record. The listed applicant is Rhigene, Inc.. It received FDA 510(k) clearance on 2004-04-02 under 510(k) number K040711. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESACUP TEST PR-3?

MESACUP TEST PR-3 is a medical device that received FDA 510(k) clearance on 2004-04-02. The listed applicant is Rhigene, Inc.. The 510(k) number is K040711.

When did MESACUP TEST PR-3 receive FDA 510(k) clearance?

MESACUP TEST PR-3 received FDA 510(k) clearance on 2004-04-02, under 510(k) number K040711.

Who is the listed applicant for MESACUP TEST PR-3?

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 MESACUP TEST PR-3?

The FDA product code for MESACUP TEST PR-3 is MOB.

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Other records listing Rhigene, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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