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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 K090239
Device Name PROGASTRO CD ASSAY
Applicant
PRODESSE, INC.
w229 n1870 westwood dr.
waukesha,  WI  53186
Contact kristine schraufnagel
Regulation Number866.2660
Classification Product Code
LLH  
Date Received02/02/2009
Decision Date 04/16/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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