Name: Predicase
Price: 199 USD

K-number	K150925
Device name	Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
Applicant	Immunalysis Corporation
Product code	DIO
Device class	Class II
Decision date	Jun 29, 2015
Decision	Substantially Equivalent
Regulation	862.3250

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Source

View the full FDA submission: accessdata.fda.gov

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Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set

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