Vaccines, Blood & Biologics

Cleared 510(k) Submissions with Supporting Documents - 2018

This list includes cleared 510(k) submissions for 2018 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) NumberApplicantDevice NameDecision Date
BK180181Immucor GTI Diagnostics, Inc.
Waukesha, WI
DonorScreen-HLA® Class I and Class II6/14/2018
BK170095RedDress Ltd
Philadelphia, PA
RD1 System6/14/2018
BK170150Biowy Corporation
Lake Forest, CA
Biowy Freezing Bags5/11/2018
BK170144Arthrex, Inc.
Naples, FL
Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (PRP) System5/10/2018
BK180175Bio-Rad Medical Diagnostic GmbH
Redmond, WA
TANGO infinity Software Version 1.55/1/2018
BK180174Bio-Rad Medical Diagnostic GmbH
Redmond, WA
IH-Com V5.05/1/2018
BK170135Immucor, Inc.
Norcross, GA
Echo Lumena™4/27/2018
BK170132Immucor, Inc.
Norcross, GA
Galileo Echo® (v.2.0)4/27/2018
BK170149Immunetics, Inc.
Boston, MA
BacTx® Bacterial Detection Kit4/16/2018
BK170157Terumo BCT, Inc.
Lakewood, CO
Trima Accel Blood Collection System4/6/2018
BK180185Haemonetics Corporation
Braintree, MA
PCS 300 Plasma Collection System3/27/2018
BK160084Diagast
Minneapolis, MN
Neg Control2/2/2018
BK170142bioMerieux, Inc.
Hazelwood, MO
BacT/ALERT BPA Culture Bottle; BacT/ALERT BPN Culture Bottle2/1/2018
BK170138Ethicon Inc.
Somerville, NJ
EVICEL™ Laparoscopic Airless Spray Accessory (35cm Rigid)1/26/2018
BK170141Helmer Inc.
Noblesville, IN
UltraCW®II Automatic Cell Washing System1/22/2018
BK170162Grifols Diagnostic Solutions, Inc.
Emeryville, CA
Procleix Xpress® System (Software v3.0)1/18/2018

 

Page Last Updated: 06/20/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English