EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine— 510(k) K151557

Name: FDA 510(k) clearance K151557
Creator: U.S. Food and Drug Administration
Published: 2015-07-16

Substantially Equivalent

Nantong Egens Biotech Co., Ltd.

FDA 510(k) clearance K151557 for EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine, Substantially Equivalent on 2015-07-16. Applicant: Nantong Egens Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nantong Egens Biotech Co., Ltd.
Product code: Code DNK
Device class: Class 2
Regulation: 21 CFR 862.3640
Advisory panel: Clinical Toxicology
Date received: 2015-06-10
Decision date: 2015-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nantong, CN

Download summary PDF View on FDA.gov ↗

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