Name: Predicase
Price: 199 USD

K-number	K083222
Device name	AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
Applicant	Axis-Shield Diagnostics, Ltd.
Product code	LPS
Device class	Class II
Decision date	Jul 31, 2009
Decision	Substantially Equivalent
Regulation	862.1377

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 →

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

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