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QM2/QM300 Buffer and Diluent Pack

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

510(k) K871343

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 NumberK871343 Date15 May 1987ClearedStatusActive

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  • Withdrawn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
CFN
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 QM2/QM300 Buffer and Diluent Pack is a method, nephelometric, immunoglobulins (G, A, M) device used in immunology testing. It is designed to support the preparation and dilution of samples for nephelometric assays measuring immunoglobulin levels.

Supplied by Kallestad Diag, a division of Erbamont, Inc., the device received FDA 510(k) clearance under K871343 on May 15, 1987, and is classified as a Class II medical device. It is intended for use in clinical laboratory settings and is not indicated as sterile, single-use, or MRI-safe based on the provided data.

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Questions

AI-generated answers, 27 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 QM2/QM300 Buffer and Diluent Pack used for?

    The QM2/QM300 Buffer and Diluent Pack is a method, nephelometric device used in immunology testing to support the preparation and dilution of samples for assays measuring immunoglobulin (G, A, M) levels in clinical laboratory settings.

  • How is the QM2/QM300 Buffer and Diluent Pack supplied?

    The device is supplied by Kallestad Diag, a division of Erbamont, Inc. It is not indicated as sterile or single-use based on the provided data, and specific packaging quantities are not detailed in the information available.

  • What is the regulatory status of the QM2/QM300 Buffer and Diluent Pack?

    The device received FDA 510(k) clearance under K871343 on May 15, 1987, and is classified as a Class II medical device. It is not indicated as MRI-safe based on the provided data.

  • What are the specifications of the QM2/QM300 Buffer and Diluent Pack?

    The device is classified under product code CFN and is intended for immunology testing. It is not indicated as sterile, single-use, or MRI-safe. The device is substantially equivalent to predicate devices used for nephelometric immunoglobulin assays.