Name: Predicase
Price: 199 USD

K-number	K120056
Device name	HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
Applicant	The Binding Site Group , Ltd.
Product code	DFH
Device class	Class II
Decision date	Apr 1, 2013
Decision	Substantially Equivalent
Regulation	866.5550

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 →

HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER

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