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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK970022
Tradename samplink
Device Name Supplies, Blood-Bank
Original Applicant
MIGADAS INC
482 hudson terrace
englewood cliffs,  NY  07632
Regulation Number864.9050
Classification Product Code
KSS  
Date Received07/15/1997
Decision Date 09/18/1997
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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