Name: Predicase
Price: 199 USD

K-number	K163336
Device name	xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
Applicant	Luminex Molecular Diagnostics, Inc.
Product code	NUA
Device class	Class II
Decision date	Dec 15, 2016
Decision	Unknown
Regulation	866.5900

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 →

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

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