Name: Predicase
Price: 199 USD

K-number	K180615
Device name	AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
Applicant	Fresenius Kabi USA,Llc
Product code	LKN
Device class	Class U
Decision date	Dec 4, 2018
Decision	Substantially Equivalent
Regulation	—

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 →

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

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