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FDA 510(k) Application Details - K201630
Device Classification Name
Enzyme Immunoassay, Opiates
More FDA Info for this Device
510(K) Number
K201630
Device Name
Enzyme Immunoassay, Opiates
Applicant
Assure Tech (Hangzhou) Co., Ltd.
2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road,
Gongshu District
Hangzhou 310011 CN
Other 510(k) Applications for this Company
Contact
Shisheng Ling
Other 510(k) Applications for this Contact
Regulation Number
862.3650
More FDA Info for this Regulation Number
Classification Product Code
DJG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2020
Decision Date
08/12/2021
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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