ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT— 510(k) K123953
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearance K123953 for ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT, Substantially Equivalent on 2013-05-02. Applicant: Alfa Wassermann Diagnostic Technologies, Inc..
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Product code
- Code KHS
- 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.