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FDA 510(k) Application Details - K081920
Device Classification Name
Reagents, Clostridium Difficile Toxin
More FDA Info for this Device
510(K) Number
K081920
Device Name
Reagents, Clostridium Difficile Toxin
Applicant
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
6146 NANCY RIDGE DR.
SAN DIEGO, CA 92121 US
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Contact
RAYMOND BOULE
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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
07/03/2008
Decision Date
12/19/2008
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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