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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name manual antimicrobial susceptibility test systems
510(k) Number K941997
Device Name BBL CRYSTAL MRSA ID SYSTEM
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 Number866.1640
Classification Product Code
JWY  
Date Received04/25/1994
Decision Date 01/27/1995
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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