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Lab-Tek Ana Test Kit

by Miles Laboratories, Inc. 510(k)

Active United States

510(k) K792184

Overview

The LAB-TEK ANA TEST KIT is an in vitro diagnostic device used to detect antinuclear antibodies through an indirect immunofluorescent method. It includes an antigen and a control for performing the test.

This device is regulated under product code DHN and was authorized by the FDA under a Traditional 510(k) clearance (K792184) on November 30, 1979. The decision was determined to be Substantially Equivalent by the Immunology advisory committee.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792184 Date30 Nov 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DHN
Device Class
Class II
Regulation
21 CFR Part 866.5100
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the LAB-TEK ANA TEST KIT used for?

    The LAB-TEK ANA TEST KIT is an in vitro diagnostic device designed to detect antinuclear antibodies. It uses an indirect immunofluorescent method to identify these antibodies in a sample.

  • What components are included in the LAB-TEK ANA TEST KIT?

    The kit includes an antigen and a control, which are essential components for performing the indirect immunofluorescent test to detect antinuclear antibodies.

  • What is the regulatory status of the LAB-TEK ANA TEST KIT?

    This device was cleared by the FDA under a Traditional 510(k) clearance (K792184) on November 30, 1979. The Immunology advisory committee determined it to be Substantially Equivalent.