Name: Predicase
Price: 199 USD

K-number	K041133
Device name	MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Applicant	Bayer Healthcare, LLC
Product code	CDD
Device class	Class II
Decision date	Jul 2, 2004
Decision	Substantially Equivalent
Regulation	862.1810

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 →

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

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