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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 K980185
Device Name COLORPAC TOXIN A
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
7loveton Cir.
Sparks,  MD  21152
Applicant Contact COLLEEN A ROHRBECK
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact COLLEEN A ROHRBECK
Regulation Number866.2660
Classification Product Code
LLH  
Date Received01/20/1998
Decision Date 07/17/1998
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
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