Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card— 510(k) K151642

Name: FDA 510(k) clearance K151642
Creator: U.S. Food and Drug Administration
Published: 2015-08-13

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K151642 for Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card, Substantially Equivalent on 2015-08-13. 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: 2015-06-18
Decision date: 2015-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Bellaire, TX, US

Download summary PDF View on FDA.gov ↗

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