CR3 Keyless Split Sample Cup Morphine - Methamphetamine— 510(k) K150602

Name: FDA 510(k) clearance K150602
Creator: U.S. Food and Drug Administration
Published: 2015-04-07

Substantially Equivalent

Guangzhou Wondfo Biotech Co., Ltd.

FDA 510(k) clearance K150602 for CR3 Keyless Split Sample Cup Morphine - Methamphetamine, Substantially Equivalent on 2015-04-07. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Wondfo Biotech Co., Ltd.
Product code: Code DNK
Device class: Class 2
Regulation: 21 CFR 862.3640
Advisory panel: Clinical Toxicology
Date received: 2015-03-10
Decision date: 2015-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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