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QM300 ALPHA2 Macroglobulin Antibody Pack

by Kallestad Diag, A Div. of Erbamont, Inc.

510(k) K896483

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 NumberK896483 Date1 Dec 1989ClearedStatusActive

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  • Withdrawn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
DEB
Device Class
Class II
Regulation
21 CFR Part 866.5620
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Qm300 Alpha2 Macroglobulin Antibody Pack is an immunological device used as an alpha-2-macroglobulin antigen, antiserum, or control. It is designed to facilitate specific testing procedures within the field of immunology.

This device is supplied by Kallestad Diag, a division of Erbamont, Inc. It has received FDA 510(k) clearance under the regulation number 866.5620 and is classified as a class 2 medical device.

Other devices from Kallestad Diag, A Div. of Erbamont, Inc.

See all devices from Kallestad Diag, A Div. of Erbamont, Inc. →

Questions

AI-generated answers, 21 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 use of the QM300 Alpha2 Macroglobulin Antibody Pack?

    This device is intended for use in immunological testing procedures. It functions as an alpha-2-macroglobulin antigen, antiserum, or control to support specific diagnostic or analytical workflows in a laboratory setting.

  • What is the regulatory status of this device?

    The QM300 Alpha2 Macroglobulin Antibody Pack has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 866.5620, which pertains to alpha-2-macroglobulin immunological test systems.

  • Who is the manufacturer of this antibody pack?

    This device is supplied by Kallestad Diag, which is a division of Erbamont, Inc., located in Chaska, Minnesota.