Name: Predicase
Price: 199 USD

K-number	K150358
Device name	Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
Applicant	Gold Standard Diagnostics
Product code	GMQ
Device class	Class II
Decision date	Nov 12, 2015
Decision	Substantially Equivalent
Regulation	866.3820

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

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