510(k) K162462
K162462 is an FDA 510(k) premarket notification submitted by Fresenius Kabi USA,Llc for the device "AMICUS Separator System, AMICUS Separator System; Refurbished". The FDA issued a decision of Substantially Equivalent on November 23, 2016. The device falls under product code GKT (Separator, Automated, Blood Cell, Diagnostic), a Class II device regulated under 21 CFR 864.9245. Fresenius Kabi USA,Llc has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2016
- Date Received
- September 2, 2016
- 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