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FDA 510(k) Application Details - K192299
Device Classification Name
Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
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510(K) Number
K192299
Device Name
Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
Applicant
Lin-Zhi International, Inc.
2945 Oakmead Village Court
Santa Clara, CA 95051 US
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Contact
Bernice Lin
Other 510(k) Applications for this Contact
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
08/23/2019
Decision Date
11/21/2019
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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