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FDA 510(k)

RHIGENE MESACUP-2 TEST RNP, MODEL M7741

K-Number: K022017 · 2002-08-14

ApplicantRhigene, Inc.
Decision Date2002-08-14
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHIGENE MESACUP-2 TEST RNP, MODEL M7741 is the device name listed in this FDA 510(k) record. The listed applicant is Rhigene, Inc.. It received FDA 510(k) clearance on 2002-08-14 under 510(k) number K022017. The device is classified under product code LKO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHIGENE MESACUP-2 TEST RNP, MODEL M7741?

RHIGENE MESACUP-2 TEST RNP, MODEL M7741 is a medical device that received FDA 510(k) clearance on 2002-08-14. The listed applicant is Rhigene, Inc.. The 510(k) number is K022017.

When did RHIGENE MESACUP-2 TEST RNP, MODEL M7741 receive FDA 510(k) clearance?

RHIGENE MESACUP-2 TEST RNP, MODEL M7741 received FDA 510(k) clearance on 2002-08-14, under 510(k) number K022017.

Who is the listed applicant for RHIGENE MESACUP-2 TEST RNP, MODEL M7741?

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 TEST RNP, MODEL M7741?

The FDA product code for RHIGENE MESACUP-2 TEST RNP, MODEL M7741 is LKO.

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Other records listing Rhigene, Inc. as applicant

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K040711MESACUP TEST PR-3K040586MESACUP TEST MPO, MODEL 11053K040200MESACUP-2 TEST CENP-BK033528MESACUP-2 TEST JO-1, MODEL 10756K031308RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760K022018RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560

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Related Devices (Code: LKO)

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.

K191085Maverick RNP Assay and Maverick Diagnostic SystemGenalyte, Inc.K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)Euroimmun USK083117ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01Phadia US, Inc.K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006Biomedical Diagnostics (Bmd) SAK000752RHIGENE MESACUP2 TEST- RNPRhigene, Inc.K993589VARELISA RNP ANTIBODIESPharmacia & Upjohn Co.

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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