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FDA 510(k) Application Details - K222955
Device Classification Name
Enzyme Immunoassay, Opiates
More FDA Info for this Device
510(K) Number
K222955
Device Name
Enzyme Immunoassay, Opiates
Applicant
Xenta Biomedical Science Co., Ltd.
Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue,
Huangpu District
Guangzhou 510535 CN
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Contact
Huang Ling
Other 510(k) Applications for this Contact
Regulation Number
862.3650
More FDA Info for this Regulation Number
Classification Product Code
DJG
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More FDA Info for this Product Code
Date Received
09/27/2022
Decision Date
02/06/2023
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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