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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solution, stabilized enzyme
510(k) Number K760123
Device Name AUTOZYME
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 Number864.9400
Classification Product Code
KSK  
Date Received06/28/1976
Decision Date 07/20/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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