K000556
Substantially EquivalentATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
- Applicant
- Elan Diagnostics
- Product code
- CFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.