Cleared 510(k) Submissions with Supporting Documents - 2017
This list includes cleared 510(k) submissions for 2017 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 |
|---|---|---|---|
| BK170114 | Arlington Scientific, Inc. Springville, UT |
ASI Automated RPR test for Syphilis for use on the ASI Evolution | 12/28/2017 |
| BK170075 | Bio-Rad Medical Diagnostic GmbH Redmond, WA |
IH-Basic QC | 12/20/2017 |
| BK170128 | Reichert, Inc. Depew, NY |
TS Meter-DSP | 12/19/2017 |
| BK170066 | Bio-Rad Medical Diagnostics GmbH Dreieich, Germany |
IH-Incubator L | 12/18/2017 |
| BK170065 | Bio-Rad Medical Diagnostics GmbH Dreieich, Germany |
IH-Centrifuge L | 12/18/2017 |
| BK170064 | Bio-Rad Medical Diagnostics GmbH Dreieich, Germany |
IH-Internal QC | 12/18/2017 |
| BK170028 | Baxalta US, Inc. Westlake Village, CA |
myPKFiT for ADVATE | 12/14/2017 |
| BK170102 | ITL Corporation, LTD Abington, MA |
Samplok® Segment Sampler | 11/27/2017 |
| BK170096 | Cascade Medical Enterprises, LLC Chapel Hill, NC |
Cascade Medical Fibrinet® System | 11/21/2017 |
| BK160095 | MacoProductions S.A.S Duluth, GA |
MacoMix HM20 and Hemolog 6 | 11/15/2017 |
| BK170085 | MacoProductions S.A.S. Duluth, GA |
MacoPress Smart (MPS) and DMS Plus | 11/09/2017 |
| BK160071 | STRATEC Biomedical UK Limited Southington, CT |
Aurora Enterprise | 10/30/2017 |
| BK160124 | STRATEC Biomedical UK Limited Southington, CT |
ORTHO CONNECT™ | 10/17/2017 |
| BK170099 | Fresenius Kabi USA, LLC Lake Zurich, IL |
AMICUS Separator System | 10/10/2017 |
| BK170053 | One Lambda, Inc. Canoga Park, CA |
LABType™ XR and CWD DNA Typing Test | 10/05/2017 |
| BK170098 | Terumo BCT, Inc. Lakewood, CO |
TSCD®-II Sterile Tubing Welder with or without Trucise Total System™ | 09/29/2017 |
| BK170071 | Bio-Rad Laboratories, Inc. Redmond, WA |
IH-Com V5.0 | 09/26/2017 |
| BK170072 | Fresenius Kabi AG Lake Zurich, IL |
DXT Data Management System v3.0 | 09/26/2017 |
| BK170057 | Fresenius Kabi AG Lake Zurich, IL |
Aurora Xi Plasmapheresis System | 08/25/2017 |
| BK170045 | Haemonetics Corporation Braintree, MA |
PCS 300 Plasma Collection System | 07/25/2017 |
| BK170033 | Baxter Healthcare Corporation Round Lake, IL |
Duploject, Duo Set and Duo Set A | 07/24/2017 |
| BK170030 | Fresenius Kabi AG Lake Zurich, IL |
Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters and Bone Marrow Collection Stand | 07/24/2017 |
| BK170067 | Immucor, Inc. Norcross, GA |
Galileo Neo® Automated Blood Bank System | 07/19/2017 |
| BK170059 | Terumo BCT, Inc. Lakewood, CO |
Trima Accel ® Automated Blood Collection System | 07/07/2017 |
| BK170032 | Epics System Corporation Verona, WI |
Blood Product Administration Module Version 2-2017 | 06/28/2017 |
| BK170013 | Alba Bioscience Limited United Kingdom |
AlbaQ-Chek® Simulated Whole Blood Controls, Model Z498 | 05/09/2017 |
| BK170019 | Bio-Rad Medical Diagnostic GmbH Redmond, WA |
IH-1000 V04.04.52 | 05/05/2017 |
| BK170021 | Bio-Rad Medical Diagnostic GmbH Redmond, WA |
IH-Com V5.0 | 05/05/2017 |
| BK160125 | STRATEC Biomedical UK Limited Southington, CT |
Procleix® NAT Manager® v1.2 Software | 04/25/2017 |
| BK160113 | STRATEC Biomedical UK Limited Southington, CT |
cobas Synergy Software (v 1.0) | 04/19/2017 |
| BK160112 | Fresenius Kabi USA, LLC Lake Zurich, IL |
AMICUS Separator System | 04/07/2017 |
| BK160087 | Verax Biomedical Inc Worcester, MA |
Platelet PGD® Test System | 04/06/2017 |
| BK170002 | Reapplix ApS Birkerod, Denmark |
3C Patch System | 04/03/2017 |
| BK170001 | Fenwal, Inc. Lake Zurich, IL |
Alyx Component Collection System | 04/03/2017 |
| BK160081 | Hemo bioscience, Inc. Morrisville, NC |
MQC-CAT | 03/30/2017 |
| BK160017 | One Lambda, Inc. Canoga Park, CA |
HLA Fusion™ Software Version 4.0 | 03/08/2017 |
| BK160018 | One Lambda, Inc. Canoga Park, CA |
LABType™ XR and CWD DNA Typing Test | 03/06/2017 |
| BK160079 | Hemo bioscience, Inc. Morrisville, NC |
MQC | 02/27/2017 |