Name: Predicase
Price: 199 USD

K-number	K142280
Device name	Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
Applicant	Healgen Scientific,, LLC
Product code	DJG
Device class	Class II
Decision date	Oct 16, 2014
Decision	Substantially Equivalent
Regulation	862.3650

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)

Everything you need for a 510(k) submission. Nothing you don't.