Cleared 510(k) Submissions with Supporting Documents - 2019
This list includes cleared 510(k) submissions for 2019 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 |
|---|---|---|---|
| BK190424 | Bio-Rad Medical Diagnostics GmbH Redmond,WA |
IH-COM V5.2 | 12/20/2019 |
| BK190401 | Fremon Scientific, Inc. La Jolla, CA |
ZipThaw™ 202 | 12/18/2019 |
| BK190400 | Micro Typing Systems, Inc. Pompeo Beach, FL |
MTS™ Buffered Gel Card | 12/17/2019 |
| BK190399 | Ortho-Clinical Diagnostic, Inc. Raritan, NJ |
ORTHO VISION® Max Analyzer | 12/17/2019 |
| BK190388 | Bio-Rad Medical Diagnostics GmbH Redmond, WA |
TANGO infinity | 12/13/2019 |
| BK190321 | Diagnostic Grifols, S.A. Barcelona, Spain |
WADiana® Compact | 12/10/2019 |
| BK190320 | Diagnostic Grifols, S.A. Barcelona, Spain |
DG Reader | 12/10/2019 |
| BK190318 | Diagnostic Grifols, S.A. Barcelona, Spain |
Erytra ® | 12/10/2019 |
| BK190333 | Terumo BCT, Inc. Lakewood, CO |
Terumo Operational Medical Equipment Software (TOMEs), Version 7.1 | 12/3/2019 |
| BK190389 | Alba Bioscience Limited Scotland |
ALBAcheck® BGS Monoclonal Control | 11/26/2019 |
| BK190349 | RedDress Ltd. Israel |
RD2 System | 11/8/2019 |
| BK190406 | Arthrex Inc. Naples, FL |
Arthrex Double Syringe (ACP) kit | 11/6/2019 |
| BK180296 | Fidia Farmaceutici S.p.A. Padua, Italy |
Fidia PRP Kit | 11/5/2019 |
| BK190379 | Diagnostic Grifols, S.A. Barcelona, Spain |
DG Reader Net | 10/11/2019 |
| BK190383 | Arthrex, Inc. Naples, FL |
Arthrex Angel System | 9/18/2019 |
| BK190361 | Alliance Technologies, LLC. Phoenix, AZ |
BloodRelay 1.0.0 | 9/17/2019 |
| BK180283 | NanoEnTek, Inc. Korea |
ADAMII™ CD34 System | 8/9/2019 |
| BK180301 | Newmarket Biomedical Ltd. United Kingdom |
PK7400 TP HA Controls and PK7400 TP HA Reagent | 8/1/2019 |
| BK190368 | Fresenius Kabi AG Lake Zurich, IL |
Aurora Plasmapheresis System, Software Version 2.1 | 7/26/2019 |
| BK190363 | Timestrip UK Ltd. United Kingdom |
Timestrip® Blood Temp 10 (BT10) | 7/19/2019 |
| BK190362 | Fresenius Kabi AG Lake Zurich, IL |
Plasmalink Bottle with Locking Luer Adapter | 7/19/2019 |
| BK190339 | Micro Typing Systems Inc. Raritan, New Jersey |
MTS™ Buffered Gel Card | 7/8/2019 |
| BK190338 | Ortho-Clinical Diagnostics, Inc. Raritan, New Jersey |
ORTHO VISION® Analyzer | 7/8/2019 |
| BK190337 | Immucor, Inc. Norcross, GA |
Galileo NEO | 6/19/2019 |
| BK190324 | ETHICON Inc. Somerville, NJ |
VISTASEAL Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) | 6/5/2019 |
| BK190351 | Fresenius Kabi USA, LLC Lake Zurich, IL |
ALYX Component Collection System | 6/4/2019 |
| BK190332 | Terumo BCT, Inc. Lakewood, CO |
Trima Accel Automated Blood Collection System | 5/22/2019 |
| BK190322 | OrSense Ltd. Israel |
NBM-200 Pulse Oximeter and Hemoglobin Monitor | 5/9/2019 |
| BK190312 | Bio-Rad Medical Diagnostics GmbH Redmond, WA |
TANGO infinity | 04/24/2019 |
| BK180287 | Ethicon, Inc. Somerville, NJ |
VISTASEAL Dual Applicator | 4/10/2019 |
| BK180252 | APEX Biologix Murry, UT |
XCELL PRP™ Platelet Concentrating System 60ml | 4/5/2019 |
| BK180275 | Bio-Rad Medical Diagnostics GmbH Redmond, WA |
IH-Com V5.0 | 3/21/2019 |
| BK180274 | Bio-Rad Medical Diagnostics GmbH Redmond, WA |
IH-500 Analyzer | 3/21/2019 |
| BK180299 | Arthrex, Inc. Naples, FL |
Arthrex Thrombinator System | 3/7/2019 |
| BK180286 | Alba Bioscience Limited United Kingdom |
ALBAcyte® IgG Sensitized Red Blood Cells II | 2/5/2019 |
| BK180306 | MacoProductions S.A.S. Duluth, GA |
MacoPress Smart Smarter and DMS Plus | 1/24/2019 |
| BK180258 | Terumo BCT, Inc. Lakewood, CO |
Vista Information System | 1/18/2019 |
| BK180280 | Medion Grifols Diagnostics AG Spain |
DG Gel Essential Control | 1/17/2019 |