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FDA 510(k)

MESACUP TEST MPO, MODEL 11053

K-Number: K040586 · 2004-03-22

ApplicantRhigene, Inc.
Decision Date2004-03-22
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MESACUP TEST MPO, MODEL 11053 is the device name listed in this FDA 510(k) record. The listed applicant is Rhigene, Inc.. It received FDA 510(k) clearance on 2004-03-22 under 510(k) number K040586. 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 MPO, MODEL 11053?

MESACUP TEST MPO, MODEL 11053 is a medical device that received FDA 510(k) clearance on 2004-03-22. The listed applicant is Rhigene, Inc.. The 510(k) number is K040586.

When did MESACUP TEST MPO, MODEL 11053 receive FDA 510(k) clearance?

MESACUP TEST MPO, MODEL 11053 received FDA 510(k) clearance on 2004-03-22, under 510(k) number K040586.

Who is the listed applicant for MESACUP TEST MPO, MODEL 11053?

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 MPO, MODEL 11053?

The FDA product code for MESACUP TEST MPO, MODEL 11053 is MOB.

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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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