K-number	K182467
Device name	Simplexa GBS Direct, Simplexa GBS Positive Control Pack
Applicant	Diasorin Molecular, LLC
Product code	NJR
Device class	Class I
Decision date	Nov 7, 2018
Decision	Substantially Equivalent
Regulation	866.3740

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Simplexa GBS Direct, Simplexa GBS Positive Control Pack

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