Name: Predicase
Price: 199 USD

K-number	K971418
Device name	CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
Applicant	Chiron Diagnostics Corp.
Product code	MOI
Device class	Class II
Decision date	Jul 17, 1997
Decision	Substantially Equivalent
Regulation	866.6010

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 →

CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER

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