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FDA 510(k)

AESKUSLIDES ANA HEP-2

K-Number: K120889 · 2012-10-15

ApplicantAesku Diagnostics
Decision Date2012-10-15
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKUSLIDES ANA HEP-2 is the device name listed in this FDA 510(k) record. The listed applicant is Aesku Diagnostics. It received FDA 510(k) clearance on 2012-10-15 under 510(k) number K120889. 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 AESKUSLIDES ANA HEP-2?

AESKUSLIDES ANA HEP-2 is a medical device that received FDA 510(k) clearance on 2012-10-15. The listed applicant is Aesku Diagnostics. The 510(k) number is K120889.

When did AESKUSLIDES ANA HEP-2 receive FDA 510(k) clearance?

AESKUSLIDES ANA HEP-2 received FDA 510(k) clearance on 2012-10-15, under 510(k) number K120889.

Who is the listed applicant for AESKUSLIDES ANA HEP-2?

The FDA 510(k) record lists Aesku Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AESKUSLIDES ANA HEP-2?

The FDA product code for AESKUSLIDES ANA HEP-2 is DHN.

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Other records listing Aesku Diagnostics 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.

K132082AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKK091859AESKU PR3K091860AESKULISA MPO, MODEL 30-7303USK081251MODIFICATION TO AESKULISA DS DNA GK081104AESKULISA ANA HEP-2, REF 30-7115USK052439AESKULISA GLIA A AND AESKULISA GLIA G

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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.K070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLCK042680RHIGENE 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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