Amresco Calcium Reagent Set

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

510(k) Number

K852657 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Amresco Urea Nitrogen (Bun) Reagents, Prod # 7123

  Class II

  FDA 510(k) K891912 Active Cleared 19 Jun 1989

• Amresco Creatinine Reagents Product #7790, 7791

  Class II

  FDA 510(k) K900666 Active Cleared 19 Apr 1990

• Amresco Product Number 7426

  Class II

  FDA 510(k) K891923 Active Cleared 20 Jun 1989

• Amresco Flow Pac Alkaline Phosphatase Buffer Conce

  Class II

  FDA 510(k) K852752 Active Cleared 23 Jul 1985

• Bun Reagent

  Class II

  FDA 510(k) K942984 Active Cleared 1 Mar 1995

• Amresco Flow Pac Random Access Liquid #4901030

  Class I

  FDA 510(k) K881056 Active Cleared 15 Nov 1988

See all devices from American Research Products Co. →

• What is the AMRESCO CALCIUM REAGENT SET used for?

  The AMRESCO CALCIUM REAGENT SET is used in clinical chemistry for the measurement of calcium in vitro, based on the cresolphthalein complexone method, as specified in its device description and authorization details.

• How is the AMRESCO CALCIUM REAGENT SET supplied and for what use?

  The reagent set is supplied for in vitro diagnostic use, meaning it is intended for laboratory testing of specimens outside the body, as stated in the device description and supported by its FDA 510(k) authorization.

• What regulatory authorization does the AMRESCO CALCIUM REAGENT SET have?

  The device is authorized under FDA 510(k) clearance K852657, classified as a Class II device under regulation number 862.1145 with product code CIC, and was found substantially equivalent through a traditional clearance pathway.