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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 K033479
Device Name PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
Applicant
Remel, Inc.
14000 Unity St. NW
Ramsey,  MN  55303
Applicant Contact DAVID TEICHER
Correspondent
Remel, Inc.
14000 Unity St. NW
Ramsey,  MN  55303
Correspondent Contact DAVID TEICHER
Regulation Number866.2660
Classification Product Code
LLH  
Date Received11/03/2003
Decision Date 02/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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