K-number	DEN190023
Device name	AmplideX Fragile X Dx & Carrier Screen Kit
Applicant	Asuragen, Inc.
Product code	OYV
Device class	Class II
Decision date	Feb 21, 2020
Decision	Not Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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AmplideX Fragile X Dx & Carrier Screen Kit

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