This list includes cleared 510(k) submissions for 2020 for which we have supporting documents available, and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.
The clearances are listed by clearance date in reverse chronological order.
|510(k) Number||Applicant||Device Name||Decision Date|
Fort Myers, FL
|PurePRP SupraPhysiologic Concentrating System||2/12/2020|
|BK190413||Fresenius Kabi AG
Lake Zurich, IL
|CompoMat G5 Plus and CompoMaster Net G5 Plus System||2/6/2020|
|HemoMix 4 (Basic version) and HemoMix 4 (Internal optional RFID installed version)||1/30/2020|
|BK190439||Immucor GTI Diagnostics, Inc.
|MATCH IT!® DNA (version 1.3)||1/21/2020|