Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast Reagent

• • Terminated Z-1529-2014 FDA Class II ·initiated 5 Mar 2014 ·on shared 510(k) K131351

  Extremely low absorbance readings.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K131351 ↗

FDA Product Code

CJE

Device Class

Class II

Regulation

21 CFR Part 862.1050

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• S40 Clinical Analyzer, S Test Alb

  Class II

  FDA 510(k) K072143 Active Cleared 14 Jul 2008

• S40 Clinical Analyzer, S Test Ip, S Test Ua

  Class I

  FDA 510(k) K072141 Active Cleared 24 Jun 2008

• Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent-C, Ace-Trislycerides Reagent

  Class I

  FDA 510(k) K113262 Active Cleared 3 Jul 2012

• Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus U.V. Reagent

  Class II

  FDA 510(k) K113374 Active Cleared 13 Jul 2012

• Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic Phosphorus U.V. Reagent, Urine Standard

  Class II

  FDA 510(k) K103615 Active Cleared 8 Sep 2011

• Ace Hemoglobin Alc(Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent

  Class II

  FDA 510(k) K113437 Active Cleared 6 Aug 2012

See all devices from Alfa Wassermann Diagnostic Technologies, Inc. →