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FDA 510(k)

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

K-Number: K112223 · 2012-09-11

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

Device Summary

EUROIMMUN ANTI-LKM-1 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 K112223. The device is classified under product code NBS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN ANTI-LKM-1 ELISA(LGG)?

EUROIMMUN ANTI-LKM-1 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 K112223.

When did EUROIMMUN ANTI-LKM-1 ELISA(LGG) receive FDA 510(k) clearance?

EUROIMMUN ANTI-LKM-1 ELISA(LGG) received FDA 510(k) clearance on 2012-09-11, under 510(k) number K112223.

Who is the listed applicant for EUROIMMUN ANTI-LKM-1 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-LKM-1 ELISA(LGG)?

The FDA product code for EUROIMMUN ANTI-LKM-1 ELISA(LGG) is NBS.

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Other records listing Euroimmun US as applicant

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Related Devices (Code: NBS)

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.

K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsInova Diagnostics, Inc.K000535QUANTA LITE LKM-1 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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