K-number	K220282
Device name	i-STAT PTplus Cartridge with the i-STAT 1 System
Applicant	Abbott Laboratories
Product code	GJS
Device class	Class II
Decision date	Jul 14, 2023
Decision	Substantially Equivalent
Regulation	864.7750

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Source

View the full FDA submission: accessdata.fda.gov

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i-STAT PTplus Cartridge with the i-STAT 1 System

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