Cleared 510(k) Submissions with Supporting Documents - 2021
This list includes cleared 510(k) submissions for 2021 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 |
|---|---|---|---|
| BK210639 | Beckman Coulter Inc. Miami, FL |
Stem Kit Reagents, stemCXP System | 12/15/2021 |
| BK210574 | Immucor, Inc. Norcross, GA |
LIFECODES LSA Class II | 11/19/2021 |
| BK210573 | Immucor, Inc. Norcross, GA |
LIFECODES LSA Class I | 11/19/2021 |
| BK210572 | Immucor, Inc. Norcross, GA |
BK210572 - MATCH IT! Antibody | 11/19/2021 |
| BK210621 | NanoEntek, Inc. Korea |
rControl RBC and PLT | 10/28/2021 |
| BK210620 | Alliance Technologies, LLC Phoenix, AZ |
BloodRelay 1.1.0 | 10/4/2021 |
| BK210607 | SCC Soft Computer Clearwater, FL |
SoftDonor Version 4.5.5.0 | 9/14/2021 |
| BK210605 | Immucor, Inc. Norcross, GA |
Galileo NEO | 9/3/2021 |
| BK210600 | Immucor, Inc. Norcross, GA |
NEO Iris | 9/3/2021 |
| BK210593 | BIQ-Health Solutions, Lda. Portugal |
Btrac | 8/13/2021 |
| BK210558 | LUVO Medical Technologies, Inc. Ontario, Canada |
World PRP | 7/23/2021 |
| BK210570 | RedDress Ltd Israel |
RD2 Ver.02 System | 6/22/2021 |
| BK210559 | Sysmex America Inc. Lincolnshire, IL |
Sysmex XN-10 Automated Hematology Analyzer | 5/27/2021 |
| BK210564 | Ortho-Clinical Diagnostics, Inc. Raritan, NJ |
ORTHO VISION® Max Analyzer | 5/13/2021 |
| BK210557 | Ortho-Clinical Diagnostics, Inc. Raritan, NJ |
ORTHO VISION® Analyzer | 5/13/2021 |
| BK210563 | Royal Biologics, Inc Hackensack, NJ |
Royal Maxx Autologous PRP Concentration System | 4/16/2021 |
| BK210556 | Sunquest Information Systems, Inc. Tucson, AZ |
Sunquest Transfusion Manager™ Version 3.0 | 4/16/2021 |
| BK210562 | Immucor, Inc. Norcross, GA |
Galileo NEO | 4/12/2021 |
| BK210560 | Immucor, Inc. Norcross, GA |
NEO Iris | 4/12/2021 |
| BK200549 | Ortho-Clinical Diagnostics, Inc. Raritan, NJ |
ORTHO Optix™ Reader | 3/10/2021 |
| BK200543 | Ranfac Corporation Avon, MA |
Ranfac Autologous Platelet Separator | 2/24/2021 |
| BK200542 | Immucor, Inc. Norcross, GA |
Capture-CMV® | 2/8/2021 |
| BK200539 | Arlington Scientific, Inc. Springville, UT |
ASI Automated RPR test for Syphilis for use on the ASI Evolution | 2/2/2021 |
| BK200471 | Reapplix A/S Denmark |
Reapplix 3C Patch System | 1/13/2021 |
| BK200548 | Bio-Rad Medical Diagnostics GmbH Dreieich, Germany |
IH-1000 | 1/12/2021 |
| BK200546 | One Lambda, Inc. Canoga Park, CA |
LABScreen Multi | 1/6/2021 |