510(k) K200530
K200530 is an FDA 510(k) premarket notification submitted by Fresenius Kabi AG for the device "AMICUS Separator System". The FDA issued a decision of Substantially Equivalent on September 11, 2020. The device falls under product code GKT (Separator, Automated, Blood Cell, Diagnostic), a Class II device regulated under 21 CFR 864.9245. Fresenius Kabi AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2020
- Date Received
- March 2, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Separator, Automated, Blood Cell, Diagnostic
- Device Class
- Class II
- Regulation Number
- 864.9245
- Review Panel
- HE
- Submission Type