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FDA 510(k) Application Details - K003306
Device Classification Name
Reagents, Clostridium Difficile Toxin
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510(K) Number
K003306
Device Name
Reagents, Clostridium Difficile Toxin
Applicant
TECHLAB, INC.
VPI RESEARCH PARK
1861 PRATT DR.
BLACKSBURG, VA 24060 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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More FDA Info for this Product Code
Date Received
10/20/2000
Decision Date
11/22/2000
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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