Cleared Traditional

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

K182654 · Safecare Biotech (Hangzhou) Co., Ltd. · Toxicology

Nov 2018

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K182654 is an FDA 510(k) clearance for the SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card, a Test, Methamphetamine, Over The Counter (Class II — Special Controls, product code NGG), submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 19, 2018, 55 days after receiving the submission on September 25, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number	K182654 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2018
Decision Date	November 19, 2018
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF