ACE Hemoglobin A1c (HbA1c) Reagent— 510(k) K170623
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, LLC
FDA 510(k) clearance K170623 for ACE Hemoglobin A1c (HbA1c) Reagent, Substantially Equivalent on 2018-02-27. Applicant: Alfa Wassermann Diagnostic Technologies, LLC.
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, LLC
- Product code
- Code LCP
- Advisory panel
- Hematology
- 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.