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FDA 510(k) Application Details - K211973
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K211973
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
Microgenics Corporation
46500 Kato Road
Fremont, CA 94538 US
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Contact
Nikhita Tandon
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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
06/25/2021
Decision Date
09/24/2021
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
N
Expedited Review
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