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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, quality control for blood banking reagents
510(k) Number BK251237
Tradename DAT Control (MTS™ DAT Card)
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Micro Typing Systems Inc.
1295 s.w. 29th ave.
pompano beach,  FL  33069
Regulation Number864.9650
Classification Product Code
KSF  
Date Received06/12/2025
Decision Date 10/10/2025
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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