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FDA 510(k) Application Details - K223162
Device Classification Name
Enzyme Immunoassay, Cannabinoids
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510(K) Number
K223162
Device Name
Enzyme Immunoassay, Cannabinoids
Applicant
Healgen Scientific LLC
5213 Maple St
Bellaire, TX 77401 US
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Contact
Jianqiu Fang
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Regulation Number
862.3870
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Classification Product Code
LDJ
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More FDA Info for this Product Code
Date Received
10/07/2022
Decision Date
03/17/2023
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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