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FDA 510(k) Application Details - K102242
Device Classification Name
Reagents, Clostridium Difficile Toxin
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510(K) Number
K102242
Device Name
Reagents, Clostridium Difficile Toxin
Applicant
GENZYME CORPORATION
31 NEW YORK AVENUE
FRAMINGHAM, MA 01701 US
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Contact
CAROL C RYERSON
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Regulation Number
866.2660
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Classification Product Code
LLH
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More FDA Info for this Product Code
Date Received
08/09/2010
Decision Date
12/21/2010
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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