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FDA 510(k) Application Details - K150602
Device Classification Name
Thin Layer Chromatography, Morphine
More FDA Info for this Device
510(K) Number
K150602
Device Name
Thin Layer Chromatography, Morphine
Applicant
GUANGZHOU WONDFO BIOTECH CO., LTD.
WONDFO SCIENTECH PARK
SOUTH CHINA UNIV. OF TECHNOLOGY
GUANGZHOU 510641 CN
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Contact
BEN CHEN
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Regulation Number
862.3640
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Classification Product Code
DNK
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More FDA Info for this Product Code
Date Received
03/10/2015
Decision Date
04/07/2015
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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