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FDA 510(k) Application Details - K030992
Device Classification Name
Reagents, Clostridium Difficile Toxin
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510(K) Number
K030992
Device Name
Reagents, Clostridium Difficile Toxin
Applicant
TECHLAB, INC.
1861 PRATT DR., STE. 1030
BLACKSBURG, VA 24060-6364 US
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Contact
DAVID M LYERLY
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Regulation Number
866.2660
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Classification Product Code
LLH
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Date Received
03/28/2003
Decision Date
07/11/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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