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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 BK860009
Tradename Amtec Anti-N Lectin
Device Name Lectins and Protectins
Original Applicant
Amtec Diagnostics International Inc.
1107 ih-45 south
conroe,  TX  77305
Regulation Number864.9550
Classification Product Code
KSI  
Date Received02/12/1986
Decision Date 09/18/1987
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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