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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, screening, for d positive fetal rbc's
510(k) Number BK110067
Tradename FMH RapidScreen
Device Name Test, Screening, For D Positive Fetal RBC’s
Original Applicant
Immucor, Inc.
3130 gateway drive
p.o. box 5625
norcross,  GA  30091 5625
Regulation Number864.7455
Classification Product Code
LIM  
Date Received11/21/2011
Decision Date 05/22/2012
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 Yes
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