Name: Predicase
Price: 199 USD

K-number	K100060
Device name	EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
Applicant	Vital Diagnostics (Manufacturing) Ptyltd
Product code	KHS
Device class	Class II
Decision date	Dec 15, 2010
Decision	Substantially Equivalent
Regulation	862.1160

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 →

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

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