BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use— 510(k) K180879

Name: FDA 510(k) clearance K180879
Creator: U.S. Food and Drug Administration
Published: 2018-12-14

Substantially Equivalent

Shanghai Venture Bio-Tech Co., Ltd.

FDA 510(k) clearance K180879 for BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use, Substantially Equivalent on 2018-12-14. Applicant: Shanghai Venture Bio-Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Venture Bio-Tech Co., Ltd.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2018-04-03
Decision date: 2018-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.