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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name system, test, automated blood grouping and antibody
510(k) Number BK010020
Tradenames ABS2000 with Version 2.05.00A Software, ABS2000 with Version 2.05.00B Software, ABS2000 with Version1.00.30A SR-2 Software
Device Name System, Test, Automated Blood Grouping and Antibody
Original Applicant
Immucor, Inc.
3130 gateway drive
p.o. box 5625
norcross,  GA  30091 5625
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received06/28/2001
Decision Date 09/24/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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