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FDA 510(k)

MESACUP-2 TEST JO-1, MODEL 10756

K-Number: K033528 · 2003-12-22

ApplicantRhigene, Inc.
Decision Date2003-12-22
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MESACUP-2 TEST JO-1, MODEL 10756 is the device name listed in this FDA 510(k) record. The listed applicant is Rhigene, Inc.. It received FDA 510(k) clearance on 2003-12-22 under 510(k) number K033528. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESACUP-2 TEST JO-1, MODEL 10756?

MESACUP-2 TEST JO-1, MODEL 10756 is a medical device that received FDA 510(k) clearance on 2003-12-22. The listed applicant is Rhigene, Inc.. The 510(k) number is K033528.

When did MESACUP-2 TEST JO-1, MODEL 10756 receive FDA 510(k) clearance?

MESACUP-2 TEST JO-1, MODEL 10756 received FDA 510(k) clearance on 2003-12-22, under 510(k) number K033528.

Who is the listed applicant for MESACUP-2 TEST JO-1, MODEL 10756?

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-2 TEST JO-1, MODEL 10756?

The FDA product code for MESACUP-2 TEST JO-1, MODEL 10756 is LLL.

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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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