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510(k) K201630

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests by Assure Tech. (Hangzhou) Co, Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2021
Date Received
June 16, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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