Cleared Traditional

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

K201120 · Safecare Biotech (Hangzhou) Co., Ltd. · Toxicology
May 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K201120 is an FDA 510(k) clearance for the SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 27, 2020, 30 days after receiving the submission on April 27, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K201120 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2020
Decision Date May 27, 2020
Days to Decision 30 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NFT — Test, Amphetamine, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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