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Hy-Tec/Manual Autoimmune Kit For Histone

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962450

by Hycor Biomedical, Inc.

Identifiers

510(k) Number
K962450 FDA 510(k)
FDA Product Code
LJM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5100 FDA 510(k)
Regulation Number
866.5100 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE is an antinuclear antibody immunological test system that measures autoimmune antibodies in serum, other body fluids, and tissues through immunochemical techniques. It detects antibodies that react with cellular nuclear constituents such as ribonucleic acid, deoxyribonucleic acid, and other nuclear molecules.

This device is supplied as a manual kit and is intended for laboratory use. It is a Class II device cleared by the FDA under 510(k) K962450 on November 25, 1996, with the product code LJM. The kit includes reagents for testing and is regulated for immunology applications.

Frequently asked questions

What is the HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE used for?

This kit is an antinuclear antibody immunological test system designed to measure autoimmune antibodies in serum, other body fluids, and tissues. It detects antibodies that react with cellular nuclear constituents such as DNA, RNA, and other nuclear molecules using immunochemical techniques.

How is the HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE supplied and intended for use?

The device is supplied as a manual kit and is intended for laboratory use only. It includes reagents for testing and is regulated for immunology applications, requiring trained personnel to perform the assay in a controlled lab environment.

What regulatory clearance does the HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE have?

The device is a Class II medical device cleared by the FDA through the 510(k) process under submission K962450, which was granted on November 25, 1996. It is identified by product code LJM and regulation number 866.5100.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K962450 FDA 510(k) - HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE, HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE by HYCOR BIOMEDICAL, INC ..., HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE (K962450) — FDA 510 (k ..., 510(k) K962450 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hycor Biomedical, Inc.

Sources (1)

  • FDA 510(k) K962450 24 fields · synced Sep 28, 2026