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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 BK110029
Tradename Ortho ProVue Analyzer Version 3.1 Patch 1 (V3.1.1)
Device Name System, Test, Automated Blood Grouping and Antibody
Original Applicant
Micro Typing Systems Inc.
1295 s.w. 29th ave.
pompano beach,  FL  33069
Regulation Number864.9175
Classification Product Code
KSZ  
Date Received06/17/2011
Decision Date 07/14/2011
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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