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FDA 510(k)

EUROIMMUN ANTI-ENA POOL ELISA (IGG)

K-Number: K112996 · 2013-04-09

ApplicantEuroimmun US
Decision Date2013-04-09
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN ANTI-ENA POOL 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 2013-04-09 under 510(k) number K112996. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN ANTI-ENA POOL ELISA (IGG)?

EUROIMMUN ANTI-ENA POOL ELISA (IGG) is a medical device that received FDA 510(k) clearance on 2013-04-09. The listed applicant is Euroimmun US. The 510(k) number is K112996.

When did EUROIMMUN ANTI-ENA POOL ELISA (IGG) receive FDA 510(k) clearance?

EUROIMMUN ANTI-ENA POOL ELISA (IGG) received FDA 510(k) clearance on 2013-04-09, under 510(k) number K112996.

Who is the listed applicant for EUROIMMUN ANTI-ENA POOL 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-ENA POOL ELISA (IGG)?

The FDA product code for EUROIMMUN ANTI-ENA POOL ELISA (IGG) is LLL.

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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.

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Related Devices (Code: LLL)

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.

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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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