Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)— 510(k) K151348

Name: FDA 510(k) clearance K151348
Creator: U.S. Food and Drug Administration
Published: 2015-08-18

Substantially Equivalent

Healgen Scientific,, LLC

FDA 510(k) clearance K151348 for Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card), Substantially Equivalent on 2015-08-18. Applicant: Healgen Scientific,, LLC. Device class: 2.

Clearance details

Applicant: Healgen Scientific,, LLC
Product code: Code LFG
Device class: Class 2
Regulation: 21 CFR 862.3910
Advisory panel: Clinical Toxicology
Date received: 2015-05-20
Decision date: 2015-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellaire, TX, US

Download summary PDF View on FDA.gov ↗

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