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FDA 510(k)

EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT

K-Number: K061239 · 2007-06-28

ApplicantEuroimmun Us, LLC
Decision Date2007-06-28
Product CodeMYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Euroimmun Us, LLC. It received FDA 510(k) clearance on 2007-06-28 under 510(k) number K061239. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT?

EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT is a medical device that received FDA 510(k) clearance on 2007-06-28. The listed applicant is Euroimmun Us, LLC. The 510(k) number is K061239.

When did EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT receive FDA 510(k) clearance?

EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT received FDA 510(k) clearance on 2007-06-28, under 510(k) number K061239.

Who is the listed applicant for EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT?

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

What is the FDA product code for EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT?

The FDA product code for EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT is MYF.

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Other records listing Euroimmun Us, LLC 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.

K070789EUROIMMUN ANTI-CCP ELISAK070763EUROIMMUN ANA IFA: HEP-20-10K061408EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KITK060700EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.K051489EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

Related Devices (Code: MYF)

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.

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A.K220924Elecsys HSV-2 IgG (08948887160)Roche DiagnosticsK181514SeraQuest HSV Type 2 Specific IgGQuest International, Inc.K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A.K152353SeraQuest HSV Type 2 Specific IgGQuest International, Inc.K103603ZEUS ELISA HSV GG-2 IGG TEST SYSTEMZeus Scientific, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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