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FDA 510(k)

TEST KIT FOR DETECTION OF ANTINUCLEAR

K-Number: K802527 · 1981-01-05

ApplicantBartels & Stout, Inc.
Decision Date1981-01-05
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TEST KIT FOR DETECTION OF ANTINUCLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Bartels & Stout, Inc.. It received FDA 510(k) clearance on 1981-01-05 under 510(k) number K802527. 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 KIT FOR DETECTION OF ANTINUCLEAR?

TEST KIT FOR DETECTION OF ANTINUCLEAR is a medical device that received FDA 510(k) clearance on 1981-01-05. The listed applicant is Bartels & Stout, Inc.. The 510(k) number is K802527.

When did TEST KIT FOR DETECTION OF ANTINUCLEAR receive FDA 510(k) clearance?

TEST KIT FOR DETECTION OF ANTINUCLEAR received FDA 510(k) clearance on 1981-01-05, under 510(k) number K802527.

Who is the listed applicant for TEST KIT FOR DETECTION OF ANTINUCLEAR?

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

What is the FDA product code for TEST KIT FOR DETECTION OF ANTINUCLEAR?

The FDA product code for TEST KIT FOR DETECTION OF ANTINUCLEAR is DHN.

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Other records listing Bartels & Stout, 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.

K802526TEST KIT FOR DETECTION OF HERPES SIMPLEXK802590DIRECT FLUORESCENT ANTIBODY KIT/HERPES

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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