Name: Predicase
Price: 199 USD

K-number	K162538
Device name	ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
Applicant	Siemens Healthcare Diagnostics
Product code	JIT
Device class	Class II
Decision date	Nov 17, 2016
Decision	Substantially Equivalent
Regulation	862.1150

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 →

ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator

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