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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
Applicant Contact kristine schraufnagel
Correspondent
PRODESSE, INC.
W229 N1870 WESTWOOD DR.
waukesha,  WI  53186
Correspondent Contact kristine schraufnagel
Regulation Number866.2660
Classification Product Code
LLH  
Date Received02/02/2009
Decision Date 04/16/2009
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
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