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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 K964864
Device Name PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
Applicant
Alexon Biomedical, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089 -1302
Applicant Contact SUSAN TURNER, PH.D.
Correspondent
Alexon Biomedical, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089 -1302
Correspondent Contact SUSAN TURNER, PH.D.
Regulation Number866.2660
Classification Product Code
LLH  
Date Received12/04/1996
Decision Date 02/04/1997
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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