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FDA 510(k)

MESACUP-2 TEST CENP-B

K-Number: K040200 · 2004-03-04

ApplicantRhigene, Inc.
Decision Date2004-03-04
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MESACUP-2 TEST CENP-B is the device name listed in this FDA 510(k) record. The listed applicant is Rhigene, Inc.. It received FDA 510(k) clearance on 2004-03-04 under 510(k) number K040200. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESACUP-2 TEST CENP-B?

MESACUP-2 TEST CENP-B is a medical device that received FDA 510(k) clearance on 2004-03-04. The listed applicant is Rhigene, Inc.. The 510(k) number is K040200.

When did MESACUP-2 TEST CENP-B receive FDA 510(k) clearance?

MESACUP-2 TEST CENP-B received FDA 510(k) clearance on 2004-03-04, under 510(k) number K040200.

Who is the listed applicant for MESACUP-2 TEST CENP-B?

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 CENP-B?

The FDA product code for MESACUP-2 TEST CENP-B is LJM.

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Other records listing Rhigene, Inc. as applicant

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K040711MESACUP TEST PR-3K040586MESACUP TEST MPO, MODEL 11053K033528MESACUP-2 TEST JO-1, MODEL 10756K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760K022017RHIGENE MESACUP-2 TEST RNP, MODEL M7741K022018RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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