ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT— 510(k) K113253

Clearance details

Applicant

Alfa Wassermann Diagnostic Technologies, Inc.

Product code

Code JJE

Device class

Class 1

Regulation

21 CFR 862.2160

Advisory panel

Clinical Chemistry

Date received

2011-11-02

Decision date

2012-05-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Caldwell, NJ, US

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• K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT2013-10-02
• K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT2013-05-02
• K123018 — ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE2013-04-23
• K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT2012-10-05
• K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT2012-08-10

Death

6

Injury

441

Malfunction

25,011

Other

1

Total

25,459

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →