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FDA 510(k) Application Details - K113139
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K113139
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
Lin-Zhi International, Inc.
670 ALMANOR AVE
SUNNYVALE, CA 94085 US
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Contact
BERNICE LIN
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Regulation Number
862.3250
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Classification Product Code
DIO
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Date Received
10/24/2011
Decision Date
11/22/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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