QM300 IGA, Antigen, Antiserum, Control

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

510(k) Number

K871940 ↗

FDA Product Code

CZP

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Platelia Toxo IgM Kit

  Class II

  FDA 510(k) K894948 Active Cleared 15 Mar 1990

• QM300 Control E

  Class II

  FDA 510(k) K883537 Active Cleared 4 Nov 1988

• Modified QM300 Rheumatoid Factor Test

  Class II

  FDA 510(k) K902462 Active Cleared 21 Jun 1990

• Kallestad QM300 Calibrator C Pack

  Class II

  FDA 510(k) K880729 Active Cleared 30 Mar 1988

• Nds Thyroxine Test Kit & Nds Thyroxine Calibrator

  Class II

  FDA 510(k) K897072 Active Cleared 29 Mar 1990

• QM300 Rheumatoid Factor Antigen Pack

  Class II

  FDA 510(k) K883536 Active Cleared 7 Sep 1988

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

• What is the QM300 IGA, Antigen, Antiserum, Control used for?

  The QM300 IGA, Antigen, Antiserum, Control is an immunology device used as a laboratory control for immunoglobulin A (IgA) antigen and antiserum testing procedures in immunology laboratory settings.

• Is the QM300 IGA Control single-use or reusable?

  The QM300 IGA, Antigen, Antiserum, Control is supplied as a laboratory control and is not specified as single-use or reusable in the device description.

• What is the regulatory status of the QM300 IGA Control?

  The QM300 IGA, Antigen, Antiserum, Control is regulated under FDA 510K clearance with product code CZP and was determined to be substantially equivalent.

• How should the QM300 IGA Control be stored?

  The QM300 IGA, Antigen, Antiserum, Control should be stored according to the manufacturer's instructions, though specific storage conditions are not detailed in the provided information.