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FDA 510(k) Application Details - K010967
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K010967
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
PAN PROBE BIOTECH, INC.
8515 ARJONS DR., SUITE A
SAN DIEGO, CA 92126 US
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Contact
ALICE H YU
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Regulation Number
862.3250
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Classification Product Code
DIO
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More FDA Info for this Product Code
Date Received
04/02/2001
Decision Date
04/17/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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