Name: Predicase
Price: 199 USD

K-number	K190076
Device name	Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
Applicant	Cepheid
Product code	OYX
Device class	Class II
Decision date	Sep 27, 2019
Decision	Substantially Equivalent
Regulation	866.6060

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 →

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

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