K951361
Substantially EquivalentDCA 2000 SYSTEM FOR HEMOGLOBIN A1C
- Applicant
- Heraeus Kulzer, Inc.
- Product code
- LCP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mishawaka, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.