Name: Predicase
Price: 199 USD

K-number	DEN180032
Device name	Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
Applicant	Cd Diagnostics, Inc.
Product code	QGN
Device class	Class II
Decision date	May 23, 2019
Decision	Not Substantially Equivalent
Regulation	866.3230

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Source

View the full FDA submission: accessdata.fda.gov

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Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit

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