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FDA 510(k)

EUROIMMUN ANTI-NRNP/SM ELISA (IGG)

K-Number: K123261 · 2013-06-12

ApplicantEuroimmun US
Decision Date2013-06-12
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN ANTI-NRNP/SM ELISA (IGG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun US. It received FDA 510(k) clearance on 2013-06-12 under 510(k) number K123261. 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 EUROIMMUN ANTI-NRNP/SM ELISA (IGG)?

EUROIMMUN ANTI-NRNP/SM ELISA (IGG) is a medical device that received FDA 510(k) clearance on 2013-06-12. The listed applicant is Euroimmun US. The 510(k) number is K123261.

When did EUROIMMUN ANTI-NRNP/SM ELISA (IGG) receive FDA 510(k) clearance?

EUROIMMUN ANTI-NRNP/SM ELISA (IGG) received FDA 510(k) clearance on 2013-06-12, under 510(k) number K123261.

Who is the listed applicant for EUROIMMUN ANTI-NRNP/SM ELISA (IGG)?

The FDA 510(k) record lists Euroimmun US as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUROIMMUN ANTI-NRNP/SM ELISA (IGG)?

The FDA product code for EUROIMMUN ANTI-NRNP/SM ELISA (IGG) is LKO.

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Other records listing Euroimmun US as applicant

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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.K083117ELIA 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) SAK022017RHIGENE MESACUP-2 TEST RNP, MODEL M7741Rhigene, Inc.K000752RHIGENE 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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