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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name susceptibility test discs, antimicrobial
510(k) Number K822832
Device Name TICARCILLIN 75MCG. SENSI-DISC
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 Number866.1620
Classification Product Code
JTN  
Date Received09/21/1982
Decision Date 10/18/1982
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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