Name: Predicase
Price: 199 USD

K-number	K033525
Device name	DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
Applicant	Dade Behring, Inc.
Product code	DCF
Device class	Class II
Decision date	Jan 12, 2004
Decision	Substantially Equivalent
Regulation	866.5040

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 MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114

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