SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card— 510(k) K182654

Name: FDA 510(k) clearance K182654
Creator: U.S. Food and Drug Administration
Published: 2018-11-19

Substantially Equivalent

Safecare Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K182654 for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card, Substantially Equivalent on 2018-11-19. Applicant: Safecare Biotech (Hangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
Product code: Code NGG
Device class: Class 2
Regulation: 21 CFR 862.3610
Advisory panel: Clinical Toxicology
Date received: 2018-09-25
Decision date: 2018-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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