ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT— 510(k) K113437
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearance K113437 for ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT, Substantially Equivalent on 2012-08-06. Applicant: Alfa Wassermann Diagnostic Technologies, Inc..
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- 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.