Name: Predicase
Price: 199 USD

K-number	K193406
Device name	CardioChek Plus Test System; CardioChek Plus Home Test System
Applicant	Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
Product code	NBW
Device class	Class II
Decision date	Feb 26, 2022
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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CardioChek Plus Test System; CardioChek Plus Home Test System

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