Name: Predicase
Price: 199 USD

K-number	K121994
Device name	DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	CDD
Device class	Class II
Decision date	Nov 30, 2012
Decision	Substantially Equivalent
Regulation	862.1810

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 VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR

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