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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 K934493
Device Name PROSPECT MICROPLATE ASSAY
Applicant
Alexon, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089
Applicant Contact SUSAN TURNER, PHD
Correspondent
Alexon, Inc.
1190 Borregas Ave.
Sunnyvale,  CA  94089
Correspondent Contact SUSAN TURNER, PHD
Regulation Number866.2660
Classification Product Code
LLH  
Date Received09/15/1993
Decision Date 09/20/1994
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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