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FDA 510(k)

ANTINUCLEAR ANTIBODY TEST KIT

K-Number: K851369 · 1985-05-15

ApplicantModern Diagnostics, Inc.
Decision Date1985-05-15
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Modern Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-05-15 under 510(k) number K851369. 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 ANTINUCLEAR ANTIBODY TEST KIT?

ANTINUCLEAR ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1985-05-15. The listed applicant is Modern Diagnostics, Inc.. The 510(k) number is K851369.

When did ANTINUCLEAR ANTIBODY TEST KIT receive FDA 510(k) clearance?

ANTINUCLEAR ANTIBODY TEST KIT received FDA 510(k) clearance on 1985-05-15, under 510(k) number K851369.

Who is the listed applicant for ANTINUCLEAR ANTIBODY TEST KIT?

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

What is the FDA product code for ANTINUCLEAR ANTIBODY TEST KIT?

The FDA product code for ANTINUCLEAR ANTIBODY TEST KIT is DHN.

Related Clinical Trials

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.

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Other records listing Modern Diagnostics, 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.

K853269PREGNA/TESTK853258BETA-HCG MICROTITER PREGNANCY TESTK853006HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCYK852840ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST

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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