Name: Predicase
Price: 199 USD

K-number	K162642
Device name	Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Applicant	Alere Scarborough, Inc.
Product code	PSZ
Device class	Class II
Decision date	Apr 10, 2017
Decision	Substantially Equivalent
Regulation	866.3328

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 →

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

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