AMRESCO Alkaline Phosphatase Reagents 7780 & 7781

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

510(k) Number

K900250 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

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 intended use of the AMRESCO Alkaline Phosphatase Reagents 7780 & 7781?

  The reagents are used for the measurement of alkaline phosphatase activity in vitro diagnostic testing within clinical chemistry laboratories. They are designed to detect alkaline phosphatase or its isoenzymes using a nitrophenylphosphate substrate system, enabling quantitative assessment of enzyme activity in patient specimens.

• How are the AMRESCO Alkaline Phosphatase Reagents 7780 & 7781 supplied and what is their regulatory classification?

  The reagents are supplied for use in laboratory settings and are authorized under FDA 510(k) clearance K900250. They are classified as Class II medical devices with product code CJE and fall under regulation number 862.1050, which governs clinical chemistry test systems.

• What regulatory pathway was used to authorize the AMRESCO Alkaline Phosphatase Reagents 7780 & 7781, and what does this indicate about their status?

  The device received authorization via the traditional FDA 510(k) pathway under clearance K900250, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance type confirms the device met regulatory requirements for safety and effectiveness based on comparison to existing technology.