Rfa-300 Rapid Flow Analyzer W/Computer

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

510(k) Number

K883020 ↗

FDA Product Code

JJF

Device Class

Class I

Regulation

21 CFR Part 862.2170

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ast Aspartate Aminotransferase Reagent

  Class II

  FDA 510(k) K851994 Active Cleared 3 Jun 1985

• Alp(Alkaline)(Phosphatase) Reagent

  Class II

  FDA 510(k) K851998 Active Cleared 30 May 1985

• Clinalyzer Model Vx-1000

  Class I

  FDA 510(k) K851638 Active Cleared 13 May 1985

• Mg Reagent

  Class I

  FDA 510(k) K852005 Active Cleared 25 Jun 1985

• Alb Bcg Reagent

  Class II

  FDA 510(k) K852007 Active Cleared 30 May 1985

• Triglycerides - Gpo Reagent

  Class I

  FDA 510(k) K890337 Active Cleared 9 Mar 1989

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