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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 non-differential
510(k) Number K760460
Device Name SCHAEDLER SELECTIVE AGAR-KV
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
JSJ  
Date Received08/17/1976
Decision Date 09/03/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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