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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tray, blood collection
510(k) Number K771370
Device Name ICROTAINEO BRAND TUBE
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON,  DC  20006
Regulation Number862.1675
Classification Product Code
GJE  
Date Received07/25/1977
Decision Date 08/03/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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