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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name culture media, selective and differential
510(k) Number K840294
Device Name GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD
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 Number866.2360
Classification Product Code
JSI  
Date Received01/24/1984
Decision Date 02/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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