Vaccines, Blood & Biologics

510(k) Blood Establishment Computer Software - 2018

Software is listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK180209 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
SafeTrace Tx 4.0.0 8/7/2018
BK180200 Mediware Information Systems, Inc.
11711 West 79th Street
Lenexa, KS
LifeTrak® 2018 7/3/2018
BK170162 Grifols Diagnostic Solutions, Inc.
4560 Horton Street
Emeryville, CA 94608
Procleix Xpress® System (Software v3.0) 1/18/2018

 

Page Last Updated: 09/06/2018
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