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FDA 510(k)

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

K-Number: K083381 · 2009-04-15

ApplicantEuroimmun Us, Inc.
Decision Date2009-04-15
Product CodeLRM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2009-04-15 under 510(k) number K083381. The device is classified under product code LRM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)?

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) is a medical device that received FDA 510(k) clearance on 2009-04-15. The listed applicant is Euroimmun Us, Inc.. The 510(k) number is K083381.

When did EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) receive FDA 510(k) clearance?

EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) received FDA 510(k) clearance on 2009-04-15, under 510(k) number K083381.

Who is the listed applicant for EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)?

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

What is the FDA product code for EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)?

The FDA product code for EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) is LRM.

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Other records listing Euroimmun Us, Inc. as applicant

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K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternK172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternK172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternK172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

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Related Devices (Code: LRM)

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.

K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbHK001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.K000477MDI DS-DNA TESTMicro Detect, Inc.K994424DIAMEDIX IS-ANTI-DSDNA TEST SYSTEMDiamedix Corp.

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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