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  6. 510(k) Blood Establishment Computer Software - 2016
  1. Substantially Equivalent 510(k) Device Information

510(k) Blood Establishment Computer Software - 2016

Software is listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK160103 BioLife Plasma Services L.P. – Baxalta US Inc.
440 N Fairway Drive, 2W-141
Vernon Hills, IL 60061
Automated Plasma Dispositioning System (APDS) Version 2.0 11/15/2016
BK160066 Mediware Information Systems, Inc.
11711, W 79th street
Lenexa, KS 66214
HCLL™ Transfusion 2015 R2 09/30/2016
BK160052 Haemonetics Corporation
4925 Robert J. Mathews Parkway, Suite 100
El Dorado Hills, CA 95762
InstaMatch 1.0.0 08/25/2016
BK160039 Healthcare-ID, Inc.
1635 Barclay Blvd
Buffalo Grove, IL 60089
Donor-ID™ 3.2 (integrated with iCASI App Android) 7/28/2016
BK160019 Haemonetics Corporation, Software Solutions
4925 Robert J. Mathews Parkway, Suite 100
El Dorado Hills, CA 95762
ElDorado Donor 4 Next Generation Donor Management Solution 1.0.0 05/17/2016
BK150343 Immucor Transplant Diagnostics, Inc.
550 West Avenue
Stamford, CT 06902-6352
LIFECODES MATCH IT! DNA Software v1.2 05/11/2016
BK160011 Blood Bank Computer Systems, Inc.
1002 15th Street, SW, Suite 120
Auburn, WA 98001
ABO Express, Version 2.0.0 04/26/2016
BK160004 LifeSouth Community Blood Centers, Inc.
4039 Newberry Road
Gainesville, FL 32607
Integrated Blood Bank Information System (IBBIS), Version 4.0 03/29/2016
BK160005 Sunquest Information Systems
250 S. Williams Blvd.
Tucson, AZ 85711
Sunquest Blood Bank and Blood Donor, version 8.0 03/25/2016
BK120014 One Lambda, Inc.
21001 Kittridge Street
Canoga Park, CA 91303
HLA Fusion™ Software, Version 3.0 03/22/2016
BK070070 One Lambda, Inc.
21001 Kittridge Street
Canoga Park, CA 91303
HLA Fusion Software v 1.0 03/22/2016
BK150360 Haemonetics Corporation Software Solutions
4925 Robert J. Matthews Parkway Suite 100
Eldorado Hills, CA 95762
SafeTrace Tx 3.12.0 03/11/2016
BK150330 Haemonetics Corporation Software Solutions
4925 Robert J. Matthews Parkway Suite 100
Eldorado Hills, CA 95762
NextGen 3.0.0 03/03/2016
BK150347 BioLife Plasma Services L.P.
One Baxter Parkway, DF3-1E
Deerfield, IL 60015
Lookback Notification System (LNS), Version 1.0 02/12/2016