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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, C. Difficile
510(k) Number K904329
Device Name CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
Applicant
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact TOM TROTTER
Correspondent
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact TOM TROTTER
Regulation Number866.2660
Classification Product Code
MCB  
Date Received09/20/1990
Decision Date 03/12/1991
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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