Name: Predicase
Price: 199 USD

K-number	DEN050002
Device name	LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
Applicant	Wako Chemicals USA, Inc.
Product code	NSF
Device class	Class II
Decision date	May 19, 2005
Decision	Not Substantially Equivalent
Regulation	866.6030

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 →

LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS

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