K-number	K180186
Device name	Stat Profile Prime Plus Analyzer System
Applicant	Nova Biomedical Corporation
Product code	GGZ
Device class	Class II
Decision date	Aug 23, 2018
Decision	Substantially Equivalent
Regulation	864.7500

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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.