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Quantimetric Plus Kappa Reagent Kit

by Kallestad Laboratories, Inc.

510(k) K855008

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK855008 Date26 Feb 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DFH
Device Class
Class II
Regulation
21 CFR Part 866.5550
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Quantimetric Plus Kappa Reagent Kit is an immunological test system that consists of reagents used to measure kappa types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues by immunochemical techniques. It is a device used in immunology. The kit is designed to measure immunoglobulin molecules.

The Quantimetric Plus Kappa Reagent Kit is supplied with a product code of DFH and is regulated under 21 CFR 866.5550. It has been cleared under FDA 510(k) number K855008. The device is intended for use in a laboratory setting and is used to measure kappa light chains in various samples.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Quantimetric Plus Kappa Reagent Kit used for?

    The kit is used to measure kappa types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues by immunochemical techniques, in a laboratory setting.

  • Is the Quantimetric Plus Kappa Reagent Kit supplied sterile?

    The description does not specify if the kit is supplied sterile, but it is intended for use in a laboratory setting where proper handling and preparation of reagents is expected.

  • What is the regulatory classification of the Quantimetric Plus Kappa Reagent Kit?

    The device is regulated under 21 CFR 866.5550 and has been cleared under FDA 510(k) number K855008, indicating it is substantially equivalent to a predicate device.