Amresco Flow Pac Carbon Dioxide (CO2) Reagents

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K870025 ↗

FDA Product Code

KMS

Device Class

Class II

Regulation

21 CFR Part 862.1160

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

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