K062118
Substantially EquivalentPOINTE 360
- Applicant
- Pointe Scientific, Inc.,
- Product code
- CFR
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.