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FDA 510(k) Application Details - K090239
Device Classification Name
Reagents, Clostridium Difficile Toxin
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510(K) Number
K090239
Device Name
Reagents, Clostridium Difficile Toxin
Applicant
PRODESSE, INC.
W229 N1870 WESTWOOD DR.
WAUKESHA, WI 53186 US
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Contact
KRISTINE SCHRAUFNAGEL
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Regulation Number
866.2660
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Classification Product Code
LLH
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Date Received
02/02/2009
Decision Date
04/16/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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