SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana— 510(k) K153646

Name: FDA 510(k) clearance K153646
Creator: U.S. Food and Drug Administration
Published: 2016-03-18

Substantially Equivalent

Safecare Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K153646 for SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana, Substantially Equivalent on 2016-03-18. Applicant: Safecare Biotech (Hangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2015-12-21
Decision date: 2016-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code DIO

view all

K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2022-01-27
K211973 — DRI Cocaine Metabolite Assay2021-09-24
K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay2020-03-12
K181499 — DRI Cocaine Metabolite Assay2018-07-06
K170293 — Emit II Plus Cocaine Metabolite Assay2017-10-25

More clearances from Safecare Biotech (Hangzhou) Co., Ltd.

view all

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