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FDA 510(k) Application Details - K192517
Device Classification Name
Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
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510(K) Number
K192517
Device Name
Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
Applicant
Psychemedics Corporation
5832 Uplander Way
Culver City, CA 90230 US
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Contact
Virginia Hill
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Regulation Number
862.3220
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Classification Product Code
MKU
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More FDA Info for this Product Code
Date Received
09/13/2019
Decision Date
04/22/2020
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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