Name: Predicase
Price: 199 USD

K-number	K191510
Device name	Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
Applicant	Hycor Biomedical
Product code	DHB
Device class	Class II
Decision date	Jul 31, 2019
Decision	Substantially Equivalent
Regulation	866.5750

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae

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