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FDA 510(k) Application Details - K993914
Device Classification Name
Reagents, Clostridium Difficile Toxin
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510(K) Number
K993914
Device Name
Reagents, Clostridium Difficile Toxin
Applicant
MERIDIAN DIAGNOSTICS, INC.
3471 RIVER HILLS DR.
CINCINNATI, OH 45244 US
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Contact
DAVID H WILLIS
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Regulation Number
866.2660
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Classification Product Code
LLH
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Date Received
11/17/1999
Decision Date
12/10/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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