Vaccines, Blood & Biologics

510(k) Blood Establishment Computer Software - 2016

Software is listed by clearance date in reverse chronological order.

510(k) NumberApplicantDevice NameDecision Date
BK160103BioLife Plasma Services L.P. – Baxalta US Inc.
440 N Fairway Drive, 2W-141
Vernon Hills, IL 60061
Automated Plasma Dispositioning System (APDS) Version 2.011/15/2016
BK160066Mediware Information Systems, Inc.
11711, W 79th street
Lenexa, KS 66214
HCLL™ Transfusion 2015 R209/30/2016
BK160052Haemonetics Corporation
4925 Robert J. Mathews Parkway, Suite 100
El Dorado Hills, CA 95762
InstaMatch 1.0.008/25/2016
BK160039Healthcare-ID, Inc.
1635 Barclay Blvd
Buffalo Grove, IL 60089
Donor-ID™ 3.2 (integrated with iCASI App Android)7/28/2016
BK160019Haemonetics Corporation, Software Solutions
4925 Robert J. Mathews Parkway, Suite 100
El Dorado Hills, CA 95762
ElDorado Donor 4 Next Generation Donor Management Solution 1.0.005/17/2016
BK150343Immucor Transplant Diagnostics, Inc.
550 West Avenue
Stamford, CT 06902-6352
LIFECODES MATCH IT! DNA Software v1.205/11/2016
BK160011Blood Bank Computer Systems, Inc.
1002 15th Street, SW, Suite 120
Auburn, WA 98001
ABO Express, Version 2.0.004/26/2016
BK160004LifeSouth Community Blood Centers, Inc.
4039 Newberry Road
Gainesville, FL 32607
Integrated Blood Bank Information System (IBBIS), Version 4.003/29/2016
BK160005Sunquest Information Systems
250 S. Williams Blvd.
Tucson, AZ 85711
Sunquest Blood Bank and Blood Donor, version 8.003/25/2016
BK120014One Lambda, Inc.
21001 Kittridge Street
Canoga Park, CA 91303
HLA Fusion™ Software, Version 3.003/22/2016
BK070070One Lambda, Inc.
21001 Kittridge Street
Canoga Park, CA 91303
HLA Fusion Software v 1.003/22/2016
BK150360Haemonetics Corporation Software Solutions
4925 Robert J. Matthews Parkway Suite 100
Eldorado Hills, CA 95762
SafeTrace Tx 3.12.003/11/2016
BK150330Haemonetics Corporation Software Solutions
4925 Robert J. Matthews Parkway Suite 100
Eldorado Hills, CA 95762
NextGen 3.0.003/03/2016
BK150347BioLife Plasma Services L.P.
One Baxter Parkway, DF3-1E
Deerfield, IL 60015
Lookback Notification System (LNS), Version 1.002/12/2016

 

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