Name: Predicase
Price: 199 USD

K-number	K201505
Device name	Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
Applicant	Diasorin Molecular, LLC
Product code	OCC
Device class	Class II
Decision date	Aug 22, 2020
Decision	Substantially Equivalent
Regulation	866.3980

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 →

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

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