Name: Predicase
Price: 199 USD

K-number	K041417
Device name	DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
Applicant	Dade Behring, Inc.
Product code	NBC
Device class	Class II
Decision date	Jul 20, 2004
Decision	Substantially Equivalent
Regulation	862.1117

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 NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423

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