Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11— 510(k) K220046

Name: FDA 510(k) clearance K220046
Creator: U.S. Food and Drug Administration
Published: 2022-12-13

Substantially Equivalent

Shenzhen Superbio Technology Co., Ltd.

FDA 510(k) clearance K220046 for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11, Substantially Equivalent on 2022-12-13. Applicant: Shenzhen Superbio Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Superbio Technology Co., Ltd.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2022-01-05
Decision date: 2022-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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