Name: Predicase
Price: 199 USD

K-number	K232286
Device name	Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
Applicant	Quidel Corporation
Product code	PGI
Device class	Class II
Decision date	Dec 20, 2023
Decision	Substantially Equivalent
Regulation	866.3309

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 →

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument

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