Name: Predicase
Price: 199 USD

K-number	K091409
Device name	LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
Applicant	Roche Molecular Systems, Inc.
Product code	NQX
Device class	Class II
Decision date	Jul 6, 2010
Decision	Substantially Equivalent
Regulation	866.1640

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 →

LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727

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