K-number	K936023
Device name	SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER
Applicant	Toa Medical Electronics USA, Inc.
Product code	GKZ
Device class	Class II
Decision date	May 2, 1994
Decision	Substantially Equivalent
Regulation	864.5220

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 →

SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER

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