K-number	K181461
Device name	Rapid-i Kit
Applicant	Vitrolife Sweden AB
Product code	MQK
Device class	Class II
Decision date	Jan 4, 2019
Decision	Substantially Equivalent
Regulation	884.6160

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Source

View the full FDA submission: accessdata.fda.gov

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Rapid-i Kit

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

Rapid-i Kit