Name: Predicase
Price: 199 USD

K-number	K152176
Device name	Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Applicant	Immunalysis Corporation
Product code	LCM
Device class	Class U
Decision date	Sep 4, 2015
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

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