Name: Predicase
Price: 199 USD

K-number	K140827
Device name	SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
Applicant	Sd Biosensor, Inc.
Product code	LCP
Device class	Class II
Decision date	Sep 30, 2015
Decision	Substantially Equivalent
Regulation	864.7470

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 →

SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set

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