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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, identification, enterobacteriaceae
510(k) Number K926017
Device Name CRYSTAL RAPID STOOL/ENTERIC 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 Number866.2660
Classification Product Code
JSS  
Date Received11/30/1992
Decision Date 03/11/1993
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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