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  1. Development & Approval Process (CBER)

2021 Biological Device Application Approvals

This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.

2021 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date
Reapplix 3C Patch System
Automated blood cell separator
The 3C Patch System is intended to be used at point-of-care for rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood.

Under the supervision of a healthcare professional, the PRP gel produced by the 3C Patch System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds.
BK200471/0 Reapplix A/S
-(b)(4)-----------------
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01/13/2021
IH-1000
Automated blood grouping and antibody test system
The IH-1000 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. In the USA, IH-1000 is “Rx only”. The IH-1000 automates pipetting of samples and reagents, incubation and centrifugation, provides reaction grading / interpretation based on results from gel card images. BK200548/0 Bio-Rad Medical Diagnostics GmbH
Bio-Rad Laboratories Inc.
6565 185th Avenue NE
Redmond, WA 98052
01/12/2021
LABScreen Multi
Test, Qualitative, for HLA, Non-Diagnostic
LABScreenMulti is intended for the detection of antibodies to human leukocyte antigens or detection of antibodies to human neutrophil antigens. BK200546/0 One Lambda, Inc.
22801 Roscoe Boulevard
West Hills, CA 91304
01/06/2021
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