Name: Predicase
Price: 199 USD

K-number	K970326
Device name	TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
Applicant	Becton Dickinson Immunocytometry Systems
Product code	GKZ
Device class	Class II
Decision date	Nov 21, 1997
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 →

TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES

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