Name: Predicase
Price: 199 USD

K-number	K162282
Device name	CardioChek Plus Test System, CardioChek Home Test System
Applicant	Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
Product code	CGA
Device class	Class II
Decision date	Dec 22, 2016
Decision	Substantially Equivalent
Regulation	862.1345

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 →

CardioChek Plus Test System, CardioChek Home Test System

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