Name: Predicase
Price: 199 USD

K-number	K151395
Device name	Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
Applicant	Immunalysis Corporation
Product code	DJR
Device class	Class II
Decision date	Jul 24, 2015
Decision	Substantially Equivalent
Regulation	862.3620

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Source

View the full FDA submission: accessdata.fda.gov

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Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets

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