K-number	K180340
Device name	Stat Profile Prime Plus Analyzer System
Applicant	Nova Biomedical Corporation
Product code	CGA
Device class	Class II
Decision date	Sep 26, 2018
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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Stat Profile Prime Plus Analyzer System

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