Cleared Traditional

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

K202453 · Safecare Biotech (Hangzhou) Co., Ltd. · Toxicology
Mar 2021
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K202453 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 March 24, 2021, 209 days after receiving the submission on August 27, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K202453 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2020
Decision Date March 24, 2021
Days to Decision 209 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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