Name: Predicase
Price: 199 USD

K-number	K031377
Device name	SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
Applicant	Dade Behring, Inc.
Product code	GKP
Device class	Class II
Decision date	Sep 8, 2003
Decision	Substantially Equivalent
Regulation	864.5400

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 →

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

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