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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 lectins and protectins
510(k) Number BK830018
Tradename Anti-A1 Lectin
Device Name Lectins and Protectins
Original Applicant
Immucor, Inc.
3130 gateway drive
p.o. box 5625
norcross,  GA  30091 5625
Regulation Number864.9550
Classification Product Code
KSI  
Date Received10/18/1983
Decision Date 11/07/1983
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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