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FDA 510(k)

ANTI NUCLEAR ANTIBODY TEST

K-Number: K791995 · 1979-10-30

ApplicantMeda Stat Diagnostics, Inc.
Decision Date1979-10-30
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI NUCLEAR ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Meda Stat Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K791995. 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 ANTI NUCLEAR ANTIBODY TEST?

ANTI NUCLEAR ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Meda Stat Diagnostics, Inc.. The 510(k) number is K791995.

When did ANTI NUCLEAR ANTIBODY TEST receive FDA 510(k) clearance?

ANTI NUCLEAR ANTIBODY TEST received FDA 510(k) clearance on 1979-10-30, under 510(k) number K791995.

Who is the listed applicant for ANTI NUCLEAR ANTIBODY TEST?

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

What is the FDA product code for ANTI NUCLEAR ANTIBODY TEST?

The FDA product code for ANTI NUCLEAR ANTIBODY TEST 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 Meda Stat 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.

K791996MULTIPLE AUTO ANTIBODY TESTK780615BLOOD CULTURE MEDIA

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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