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

• • Terminated Z-0743-2013 FDA Class II ·initiated 10 Oct 2012 ·via K103615, on the same 510(k)

  Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K103615 ↗

FDA Product Code

CDN

Device Class

Class II

Regulation

21 CFR Part 862.1770

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 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

• S- Test Hemoglobin Alc (HBA1C), Model RC0023

  Class II

  FDA 510(k) K091711 Active Cleared 11 Dec 2009

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