Name: Predicase
Price: 199 USD

K-number	K223591
Device name	cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
Applicant	Roche Molecular Systems, Inc.
Product code	QOF
Device class	Class II
Decision date	Jul 27, 2023
Decision	Substantially Equivalent
Regulation	866.3981

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 →

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

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