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FDA 510(k)

Zeus IFA ANA HEp-2 Test System, Zeus dIFine

K-Number: K201956 · 2022-04-29

ApplicantZeus Scientific, Inc.
Decision Date2022-04-29
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Zeus IFA ANA HEp-2 Test System, Zeus dIFine is a medical device manufactured by Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2022-04-29 under approval number K201956. 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 Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

Zeus IFA ANA HEp-2 Test System, Zeus dIFine is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Zeus Scientific, Inc.. The 510(k) number is K201956.

When was Zeus IFA ANA HEp-2 Test System, Zeus dIFine approved by the FDA?

Zeus IFA ANA HEp-2 Test System, Zeus dIFine received FDA 510(k) clearance on 2022-04-29, under approval number K201956.

What company makes Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

Zeus IFA ANA HEp-2 Test System, Zeus dIFine is manufactured by Zeus Scientific, Inc..

What is the FDA product code for Zeus IFA ANA HEp-2 Test System, Zeus dIFine?

The FDA product code for Zeus IFA ANA HEp-2 Test System, Zeus dIFine is DHN.

Other Devices by Zeus Scientific, Inc.

K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System PMA P150045ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG PMA P150042ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM

Related Devices (Code: DHN)

K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.Kg K160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd. K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, 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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