K951685
Substantially EquivalentAURAFLEX TESTOSTERONE CALIBRATOR PACK
- Applicant
- Organon Teknika Corp.
- Product code
- CDZ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.