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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 K963845
Device Name MEROPENEM, 10 MCG, SENSI-DISC
Applicant
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030 -0243
Applicant Contact ROBERT E JAMES
Correspondent
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030 -0243
Correspondent Contact ROBERT E JAMES
Regulation Number866.1620
Classification Product Code
JTN  
Date Received09/25/1996
Decision Date 10/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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