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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 the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific. It received FDA 510(k) clearance on 2023-08-31 under 510(k) 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. The listed applicant is Zeus Scientific. The 510(k) number is K231616.

When did ZEUS IFA(TM) nDNA Test System, ZEUS dIFine receive FDA 510(k) clearance?

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

Who is the listed applicant for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine?

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

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 records listing Zeus Scientific as applicant

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K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBK250666Alegria Flash CTD ScreenK250408Alegria Flash ENA ScreenK243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitK201956Zeus IFA ANA HEp-2 Test System, Zeus dIFine

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Related Devices (Code: KTL)

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.

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