Name: Predicase
Price: 199 USD

K-number	K983618
Device name	DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
Applicant	Rockwell Medical Technologies, Inc.
Product code	KPO
Device class	Class II
Decision date	Aug 5, 1999
Decision	Substantially Equivalent
Regulation	876.5820

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 →

DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE

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