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72 Determ. Size Radial Immuno. Test Human Cerulopl

FDA 510(k)

Class II (US FDA 510(k))

510(k) K850682

by Kent Laboratories, Inc.

Identifiers

510(k) Number
K850682 FDA 510(k)
FDA Product Code
DDB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5210 FDA 510(k)
Regulation Number
866.5210 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL is a ceruloplasmin immunological test system that uses reagents to measure ceruloplasmin, a copper-transporting serum protein, in serum, other body fluids, or tissues through immunochemical techniques. This measurement aids in the diagnosis of copper metabolism disorders.

The device is manufactured by Kent Laboratories, Inc. and is authorized under FDA 510(k) clearance K850682 with product code DDB. It is classified as a Class II device and is intended for use in immunology testing. The device is supplied as a radial immunodiffusion test system for determining ceruloplasmin levels.

Frequently asked questions

What is the purpose of the 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL?

This test system measures ceruloplasmin, a copper-transporting serum protein, in serum, other body fluids, or tissues through immunochemical techniques to aid in diagnosing copper metabolism disorders.

How is the 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL supplied?

The device is supplied as a radial immunodiffusion test system specifically designed for determining ceruloplasmin levels in clinical laboratory settings.

What is the regulatory status of this device?

The device is manufactured by Kent Laboratories, Inc. and is authorized under FDA 510(k) clearance K850682 with product code DDB, classified as a Class II device for immunology testing.

What biological samples can be tested with this system?

The test system can measure ceruloplasmin levels in serum, other body fluids, or tissues using immunochemical techniques to assist in copper metabolism disorder diagnosis.

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: 72 Determ. Size Radial Immuno. Test Human Cerulopl, PDF K850682 72 Determ. Size Radial Immuno. Test Human Cerulopl, fda.innolitics.com, FDA Product Code DDB - Ceruloplasmin, Antigen, Antiserum, Control

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kent Laboratories, Inc.

Sources (1)

  • FDA 510(k) K850682 24 fields · synced Sep 24, 2026