POINTE 360— 510(k) K062118
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K062118 for POINTE 360, Substantially Equivalent on 2007-07-13. Applicant: Pointe Scientific, Inc.,. Device class: 2.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
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More clearances from Pointe Scientific, Inc.,
view allData sourced from openFDA. This site is unofficial and independent of the FDA.