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FDA 510(k) Application Details - K142609
Device Classification Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
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510(K) Number
K142609
Device Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
Wondfo Scientech Park, South China univ. of technology
Guangzhou CN
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Contact
Ben Chen
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Regulation Number
862.3910
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Classification Product Code
LFG
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Date Received
09/16/2014
Decision Date
12/18/2014
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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