Liquispex Liquid B2M Control Level 1 And 2

No FDA recalls on record, checked 22 Oct 2026.

Full name

Liquispex(Tm) Liquid B2M Control Level 1 and 2

510(k) Number

K946048 ↗

FDA Product Code

JZG

Device Class

Class II

Regulation

21 CFR Part 866.5630

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Liquispex(Tm) Liquid B2M/Crp Control Level 1 and 2

  Class I

  FDA 510(k) K946049 Active Cleared 10 Feb 1995

• Liquispex Urine (Micro)Albumin Control

  Class I

  FDA 510(k) K962432 Active Cleared 5 Jul 1996

• Plasma Fibrinogen Control Level 1/Level 2

  Class II

  FDA 510(k) K935598 Active Cleared 2 May 1995

• Chemspex(Tm) Ammonia Control

  Class I

  FDA 510(k) K946143 Active Cleared 3 Feb 1995

• Whole Blood Glucose Control Level 1, 2, and 3/Whole Blood Glucose Linearity Control-LEVEL1, 2, 3, 4, 5, and 6

  Class I

  FDA 510(k) K964278 Active Cleared 22 Nov 1996

• Liquispex(Tm) Liquid Crp Control Level 1 and 2

  Class II

  FDA 510(k) K946050 Active Cleared 10 Feb 1995

See all devices from Clinical Controls, Inc. →

• What is the LIQUISPEX(TM) Liquid B2M Control Level 1 and 2 used for?

  It is used for the in vitro quantitative measurement of beta-2-microglobulin in human serum as a liquid control within the Liquispex test system, ensuring assay accuracy and reliability.

• How is the LIQUISPEX(TM) Liquid B2M Control supplied and is it single-use?

  It is supplied as a liquid control formulation designed for use with the Liquispex test system; while the data does not explicitly state single-use or reuse, as a liquid control for diagnostic testing, it is intended for single-use to prevent contamination and ensure consistent performance.

• What regulatory clearance does the LIQUISPEX(TM) Liquid B2M Control have?

  The device has received FDA 510(k) clearance under number K946048, determined to be substantially equivalent to a predicate device, and is classified as Class II under FDA regulation 866.5630.