Name: Predicase
Price: 199 USD

K-number	K181436
Device name	OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
Applicant	SEKISUI Diagnostics, LLC
Product code	KTN
Device class	Class II
Decision date	Jun 22, 2018
Decision	Substantially Equivalent
Regulation	866.5640

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

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