Name: Predicase
Price: 199 USD

K-number	K182479
Device name	NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
Applicant	Hycor Biomedical
Product code	DHB
Device class	Class II
Decision date	Dec 4, 2018
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

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