Name: Predicase
Price: 199 USD

K-number	K151348
Device name	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)
Applicant	Healgen Scientific,, LLC
Product code	LFG
Device class	Class II
Decision date	Aug 18, 2015
Decision	Substantially Equivalent
Regulation	862.3910

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Source

View the full FDA submission: accessdata.fda.gov

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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)

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