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510(k) K250803

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup by Anhui Deepblue Medical Technological Co., Ltd. — Product Code NGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2025
Date Received
March 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Opiates, Over The Counter
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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