Name: Predicase
Price: 199 USD

K-number	K060628
Device name	DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
Applicant	Dade Behring, Inc.
Product code	CIG
Device class	Class II
Decision date	Apr 6, 2006
Decision	Substantially Equivalent
Regulation	862.1110

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 →

DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR

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