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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Clostridium Difficile Toxin
510(k) Number K925329
Device Name CULTURETTE BRAND TOXIN CD TEST
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 987
Columbus,  NE  68602 -0987
Applicant Contact ROBERT E JAMES
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
P.O. Box 987
Columbus,  NE  68602 -0987
Correspondent Contact ROBERT E JAMES
Regulation Number866.2660
Classification Product Code
LLH  
Date Received10/21/1992
Decision Date 03/24/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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