Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)— 510(k) K142280

Name: FDA 510(k) clearance K142280
Creator: U.S. Food and Drug Administration
Published: 2014-10-16

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K142280 for Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card), Substantially Equivalent on 2014-10-16. 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: 2014-08-15
Decision date: 2014-10-16
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.