Name: Predicase
Price: 199 USD

K-number	K150275
Device name	Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
Applicant	Immunalysis Corporation
Product code	DJG
Device class	Class II
Decision date	Mar 9, 2015
Decision	Substantially Equivalent
Regulation	862.3650

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Source

View the full FDA submission: accessdata.fda.gov

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Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls

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