SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card— 510(k) K202453

Name: FDA 510(k) clearance K202453
Creator: U.S. Food and Drug Administration
Published: 2021-03-24

Substantially Equivalent

Safecare Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K202453 for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card, Substantially Equivalent on 2021-03-24. Applicant: Safecare Biotech (Hangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
Product code: Code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2020-08-27
Decision date: 2021-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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K191924 — SAFECARE® THC Urine Strip Test2019-08-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.