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FDA 510(k)

EUROIMMUN ANTI-SLA/LP ELISA(LGG)

K-Number: K112221 · 2012-09-11

ApplicantEuroimmun US
Decision Date2012-09-11
Product CodeNIY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN ANTI-SLA/LP ELISA(LGG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun US. It received FDA 510(k) clearance on 2012-09-11 under 510(k) number K112221. 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 ANTI-SLA/LP ELISA(LGG)?

EUROIMMUN ANTI-SLA/LP ELISA(LGG) is a medical device that received FDA 510(k) clearance on 2012-09-11. The listed applicant is Euroimmun US. The 510(k) number is K112221.

When did EUROIMMUN ANTI-SLA/LP ELISA(LGG) receive FDA 510(k) clearance?

EUROIMMUN ANTI-SLA/LP ELISA(LGG) received FDA 510(k) clearance on 2012-09-11, under 510(k) number K112221.

Who is the listed applicant for EUROIMMUN ANTI-SLA/LP ELISA(LGG)?

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-SLA/LP ELISA(LGG)?

The FDA product code for EUROIMMUN ANTI-SLA/LP ELISA(LGG) 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)K113439EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)K112996EUROIMMUN ANTI-ENA POOL ELISA (IGG)

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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.

K113439EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)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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