Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card— 510(k) K163704

Name: FDA 510(k) clearance K163704
Creator: U.S. Food and Drug Administration
Published: 2017-08-02

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K163704 for Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card, Substantially Equivalent on 2017-08-02. Applicant: Healgen Scientific,, LLC. Device class: 2.

Clearance details

Applicant: Healgen Scientific,, LLC
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 2016-12-29
Decision date: 2017-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Bellaire, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.