ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT— 510(k) K113262
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearance K113262 for ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT, Substantially Equivalent on 2012-07-03. Applicant: Alfa Wassermann Diagnostic Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
Recent devices under product code CHH
view allMore clearances from Alfa Wassermann Diagnostic Technologies, Inc.
view all- K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
- K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
- K123018 — ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
- K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
- K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.