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FDA 510(k)

EUROIMMUN ANA IFA: HEP-20-10

K-Number: K070763 · 2007-05-22

ApplicantEuroimmun Us, LLC
Decision Date2007-05-22
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EUROIMMUN ANA IFA: HEP-20-10 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 2007-05-22 under 510(k) number K070763. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROIMMUN ANA IFA: HEP-20-10?

EUROIMMUN ANA IFA: HEP-20-10 is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is Euroimmun Us, LLC. The 510(k) number is K070763.

When did EUROIMMUN ANA IFA: HEP-20-10 receive FDA 510(k) clearance?

EUROIMMUN ANA IFA: HEP-20-10 received FDA 510(k) clearance on 2007-05-22, under 510(k) number K070763.

Who is the listed applicant for EUROIMMUN ANA IFA: HEP-20-10?

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 ANA IFA: HEP-20-10?

The FDA product code for EUROIMMUN ANA IFA: HEP-20-10 is DHN.

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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 ELISAK061239EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KITK061408EUROIMMUN 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: DHN)

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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.KgK160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K120889AESKUSLIDES ANA HEP-2Aesku DiagnosticsK042680RHIGENE HEP-ANA TEST SYSTEMCorgenix, 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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