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  1. Substantially Equivalent 510(k) Device Information

Cleared 510(k) Submissions with Supporting Documents - 2020

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
BK190317 EmCyte Corporation
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
BK190429 Delcon S.R.L.
Italy
HemoMix 4 (Basic version) and HemoMix 4 (Internal optional RFID installed version) 1/30/2020
BK190439 Immucor GTI Diagnostics, Inc.
Waukeshaha, WI
MATCH IT!® DNA (version 1.3) 1/21/2020