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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 K852044
Device Name CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
Applicant
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Applicant Contact WILLIAM H GUINTY
Correspondent
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Correspondent Contact WILLIAM H GUINTY
Regulation Number866.2660
Classification Product Code
LLH  
Date Received05/09/1985
Decision Date 07/19/1985
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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