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510(k) K191924

SAFECARE® THC Urine Strip Test by Safecare Biotech (Hangzhou) Co., Ltd. — Product Code NFW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2019
Date Received
July 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Cannabinoid, Over The Counter
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)

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