ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT— 510(k) K122757
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearance K122757 for ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT, Substantially Equivalent on 2012-10-05. Applicant: Alfa Wassermann Diagnostic Technologies, Inc..
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Product code
- Code CHH
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.