QM300 Calibrator B Pack

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K875282 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

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 Calibrator B Pack used for?

  The QM300 Calibrator B Pack is a multi-analyte mixture device used for calibrating laboratory instruments in clinical chemistry testing. It helps ensure accurate measurement of various analytes in patient samples by providing standardized reference values.

• How is the QM300 Calibrator B Pack supplied and is it reusable?

  The QM300 Calibrator B Pack is supplied as a complete pack and is intended for single-use only in laboratory settings. It should not be reused or repurposed after initial use to maintain calibration accuracy and ensure patient safety.

• What are the regulatory specifications for the QM300 Calibrator B Pack?

  The QM300 Calibrator B Pack is classified under product code JIX and regulated under 862.1150. It received FDA 510(k) clearance with number K875282 on 1988-02-17, with a decision of substantially equivalent, meaning it is deemed to have the same intended use and safety profile as legally marketed devices.

• Is the QM300 Calibrator B Pack MRI safe?

  The device is not specified as MRI safe. It is designed for laboratory use in clinical chemistry testing and should not be used in MRI environments unless specifically validated for such conditions by the manufacturer.