Quantimetric Plus Lambda Reagent Kit

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

510(k) Number

K855007 ↗

FDA Product Code

DEH

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Kallestad Laboratories, Inc. →

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

  The Quantimetric Plus Lambda Reagent Kit is used in immunology for the detection of lambda antigen, antiserum, or control substances, as specified in its device description and classification under product code DEH and regulation 866.5550.

• Who manufactures the Quantimetric Plus Lambda Reagent Kit and where are they located?

  The kit is manufactured by Kallestad Laboratories, Inc., located at 1000 Lake Hazeltine Dr., Chaska, MN 55318, United States, as indicated in the device authorization and establishment registration details.

• What regulatory pathway was used for the Quantimetric Plus Lambda Reagent Kit and when was it cleared?

  The device received FDA 510(k) clearance through a traditional submission process, with clearance granted on February 26, 1986, under K855007, following receipt of the application on December 16, 1985.