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FDA 510(k)

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)

K-Number: K113439 · 2013-04-12

ApplicantEuroimmun US
Decision Date2013-04-12
Product CodeNIY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (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 2013-04-12 under 510(k) number K113439. The device is classified under product code NIY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)?

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) is a medical device that received FDA 510(k) clearance on 2013-04-12. The listed applicant is Euroimmun US. The 510(k) number is K113439.

When did EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) receive FDA 510(k) clearance?

EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) received FDA 510(k) clearance on 2013-04-12, under 510(k) number K113439.

Who is the listed applicant for EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (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 EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)?

The FDA product code for EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) is NIY.

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Other records listing Euroimmun US as applicant

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.

K161513Anti-Borrelia burgdorferi US Westernblot (IgG)K12366025-OH VITAMIN D ELISAK131185ANA SCREEN ELISA (IGG)K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)K112221EUROIMMUN ANTI-SLA/LP ELISA(LGG)

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Related Devices (Code: NIY)

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.

K112221EUROIMMUN ANTI-SLA/LP ELISA(LGG)Euroimmun USK021482QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISAInova Diagnostics, Inc.

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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