Name: Predicase
Price: 199 USD

K-number	K100321
Device name	DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
Applicant	Siemens Healthcare Diagnostics
Product code	LTK
Device class	Class II
Decision date	Apr 12, 2011
Decision	Substantially Equivalent
Regulation	866.6010

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 VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

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