Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)— 510(k) K143187

Name: FDA 510(k) clearance K143187
Creator: U.S. Food and Drug Administration
Published: 2015-01-27

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K143187 for Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card), Substantially Equivalent on 2015-01-27. Applicant: Healgen Scientific,, LLC. Device class: 2.

Clearance details

Applicant: Healgen Scientific,, LLC
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2014-11-05
Decision date: 2015-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
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.