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FDA 510(k)

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

K-Number: K231616 · 2023-08-31

ApplicantZeus Scientific
Decision Date2023-08-31
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is a medical device manufactured by Zeus Scientific. It received FDA 510(k) clearance on 2023-08-31 under approval number K231616. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is a medical device that received FDA 510(k) clearance on 2023-08-31. It is manufactured by Zeus Scientific. The 510(k) number is K231616.

When was ZEUS IFA(TM) nDNA Test System, ZEUS dIFine approved by the FDA?

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine received FDA 510(k) clearance on 2023-08-31, under approval number K231616.

What company makes ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is manufactured by Zeus Scientific.

What is the FDA product code for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

The FDA product code for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine is KTL.

Other Devices by Zeus Scientific

K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit K250666Alegria Flash CTD Screen K250408Alegria Flash ENA Screen K243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

Related Devices (Code: KTL)

K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc. K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc. K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc. K203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.

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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