510(k) K192150
K192150 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 November 13, 2019. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Fresenius Kabi AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2019
- Date Received
- August 9, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type