SAFECARE® THC Urine Strip Test— 510(k) K191924

Name: FDA 510(k) clearance K191924
Creator: U.S. Food and Drug Administration
Published: 2019-08-16

Substantially Equivalent

Safecare Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K191924 for SAFECARE® THC Urine Strip Test, Substantially Equivalent on 2019-08-16. Applicant: Safecare Biotech (Hangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
Product code: Code NFW
Device class: Class 2
Regulation: 21 CFR 862.3870
Advisory panel: Clinical Toxicology
Date received: 2019-07-18
Decision date: 2019-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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