Name: Predicase
Price: 199 USD

K-number	K010597
Device name	SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
Applicant	Beckman Coulter, Inc.
Product code	DCK
Device class	Class II
Decision date	May 29, 2001
Decision	Substantially Equivalent
Regulation	866.5270

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 →

SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT

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