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Chemmate Lambda

by Ventana Medical Systems, Inc.

510(k) K973392

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 NumberK973392 Date3 Oct 1997ClearedStatusActive

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  • Withdrawn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
DEM
Device class
Class II
Regulation
21 CFR Part 866.5130
Advisory committee
Immunology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

Chemmate Lambda is a rabbit polyclonal anti-human lambda light chain reagent used for laboratory applications. It is designed to qualitatively identify human lambda light chains through the use of light microscopy.

This device is classified as an alpha-1-antitrypsin, antigen, antiserum, control under regulation 866.5130. It has received FDA 510(k) clearance under the number K973392.

Other devices from Ventana Medical Systems

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Questions

AI-generated answers, 25 Sep 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 primary application of the Chemmate Lambda reagent?

    This reagent is used in laboratory settings to qualitatively identify human lambda light chains. It is specifically designed for visualization through the use of light microscopy.

  • What type of antibody is used in this device?

    Chemmate Lambda is formulated as a rabbit polyclonal anti-human lambda light chain reagent, which allows it to bind to specific targets for identification during laboratory testing.

  • Has this device undergone regulatory review?

    Yes, this device has received FDA 510(k) clearance under the number K973392. It is classified under regulation 866.5130 as an alpha-1-antitrypsin, antigen, antiserum, control.