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FDA 510(k)

TEST SYS. FOR NDNA ANTIBODY DETERM.

K-Number: K780178 · 1978-02-13

ApplicantZeus Scientific, Inc.
Decision Date1978-02-13
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TEST SYS. FOR NDNA ANTIBODY DETERM. is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1978-02-13 under 510(k) number K780178. 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 TEST SYS. FOR NDNA ANTIBODY DETERM.?

TEST SYS. FOR NDNA ANTIBODY DETERM. is a medical device that received FDA 510(k) clearance on 1978-02-13. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K780178.

When did TEST SYS. FOR NDNA ANTIBODY DETERM. receive FDA 510(k) clearance?

TEST SYS. FOR NDNA ANTIBODY DETERM. received FDA 510(k) clearance on 1978-02-13, under 510(k) number K780178.

Who is the listed applicant for TEST SYS. FOR NDNA ANTIBODY DETERM.?

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

What is the FDA product code for TEST SYS. FOR NDNA ANTIBODY DETERM.?

The FDA product code for TEST SYS. FOR NDNA ANTIBODY DETERM. is DHN.

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Other records listing Zeus Scientific, Inc. 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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.K120889AESKUSLIDES ANA HEP-2Aesku DiagnosticsK070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLC

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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