Cleared 510(k) Submissions with Supporting Documents - 2023
This list includes cleared 510(k) submissions for 2023 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 |
|---|---|---|---|
| BK230961 | Beckman Coulter, Inc. Miami, FL |
AQUIOS CL Flow Cytometer and AQUIOS Stem Kit | 9/1/2023 |
| BK230844 | Biomet Biologics, Inc. Warsaw, IN |
nSTRIDE® PRP Concentration System | 8/9/2023 |
| BK230971 | Bio-Rad Medical Diagnostics GmbH Redmond, WA |
IH-500 | 8/9/2023 |
| BK230839 | Roche Diagnostics Indianapolis, IN |
Elecsys Syphilis; PreciControl Syphilis; PreciControl Release Syphilis | 7/31/2023 |
| BK230833 | Beckman Coulter, Inc. Chaska, MN |
Access HIV Ag/Ab combo; Access HIV Ag/Ab combo Calibrators; Access HIV Ag/Ab combo QC | 7/27/2023 |
| BK230843 | Terumo BCT Lakewood, CO |
Reveos® Automated Whole Blood Processing System | 7/27/2023 |
| BK230838 | Terumo BCT Lakewood, CO |
IMUGARD WB PLT Platelet Pooling Set | 7/27/2023 |
| BK230811 | Diagnostic Grifols, S. A. Barcelona, Spain |
Blood Typing Manager, version 3.0 | 7/24/2023 |
| BK230835 | Becton, Dickinson & Company San Jose, CA |
BD Leucocount™ Kit; BD FACSuite™ Clinical BD Leucocount™ Assay Module; BD FACSLyric™ Flow Cytometer | 7/24/2023 |
| BK230826 | WellSky Corporation Overland Park, KS |
WellSky® Transfusion 2022 R3 | 7/19/2023 |
| BK220791 | GPI USA, Inc. Houston, TX |
e-Delphyn Donor | 6/26/2023 |
| BK230820 | Diagnostic Grifols, S.A. Barcelona, Spain |
Erytra Eflexis | 6/22/2023 |
| BK220798 | Haemonetics Corporation Boston, MA |
NexSys PCS® Plasma Collection System with Express®Plus Technology | 6/20/2023 |
| BK220668 | Alma Lasers, Inc. | VorFat System | 6/12/2023 |
| BK230818 | YTS Global Inc. Springfield, VA |
Dr. PRP | 5/31/2023 |
| BK230807 | Genesis Biologics, Inc. | Adaptive Autologous Processing System | 5/10/2023 |
| BK220779 | Immucor, Inc. Norcross, GA |
Capture Positive Control Cell | 5/10/2023 |
| BK230806 | Immucor, Inc. Norcross, GA |
ImmuLINK (v3.0) | 4/25/2023 |
| BK230824 | Fresenius Kabi AG Lake Zurich, IL |
AMICUS Separator System | 4/21/2023 |
| BK230804 | Roche Diagnostics Indianapolis, IN |
Elecsys HIV Duo | 4/4/2023 |
| BK220790 | Blood Bank Computer Systems, Inc Bonney Lake, WA |
Blood Bank Control System, Version 6.0 | 2/17/2023 |
| BK220775 | Hydra Srl Italy |
Procedure Tray - Lipoaspirate fat harvest and injection kit | 1/4/2023 |