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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 powders, antimicrobial
510(k) Number K855106
Device Name IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
MACK CENTRE DR.
P.O.BOX 2224
PARAMUS,  NJ  07652
Applicant Contact RUSSELL ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
MACK CENTRE DR.
P.O.BOX 2224
PARAMUS,  NJ  07652
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number866.1640
Classification Product Code
JTT  
Date Received12/23/1985
Decision Date 03/06/1986
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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