Cleared 510(k) Submissions with Supporting Documents - 2022
This list includes cleared 510(k) submissions for 2022 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 |
|---|---|---|---|
| BK210653 | Millipore (UK) Ltd. United Kingdom |
ORTHO™ Daily QC Simulated Whole Blood Quality Control Kit | 6/7/2022 |
| BK210631 | Sysmex America, Inc. Lincolnshire, IL |
Sysmex XN-10 Automated Hematology Analyzer | 5/23/2022 |
| BK200540 | Arteriocyte Medical Systems, Inc. Hopkinton, MA |
Precise Cell Concentration System | 3/17/2022 |
| BK220674 | MicroAire Surgical Instruments, LLC. Charlottesville, VA |
MicroAire LipoFilter® System | 3/16/2022 |
| BK210635 | Terumo BCT, Inc. Lakewood, CO |
Rika Plasma Donation System; Rika Plasma Separation Set; Rika Plasma Bottle | 3/7/2022 |
| BK210625 | Bio-Rad Medical Diagnostics GmbH Dreieich, Germany |
IH-500 | 2/28/2022 |
| BK210632 | Royal Biologics, Inc. Hackensack, NJ |
Royal MAXX PRP Concentration System | 2/11/2022 |
| BK210591 | Terumo BCT, Inc Lakewood, CO |
Platelet-Rich Plasma (PRP) Procedure Pack | 2/11/2022 |
| BK210652 | Becton, Dickinson and Company San Jose, CA |
BD® Stem Cell Enumeration Kit | 1/27/2022 |
| BK210650 | CSL Plasma Knoxville, TN |
LOGIC 4.0.8 | 1/25/2022 |
| BK210649 | Becton, Dickinson & Company Franklin Lakes, NJ |
BD Vacutainer ACD A Blood Collection Tube; BD Vacutainer ACD B Blood Collection Tube | 1/21/2022 |