K-number	DEN200070
Device name	Simple 2 Test
Applicant	Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)
Product code	QYA
Device class	Class II
Decision date	Nov 15, 2023
Decision	Not Substantially Equivalent
Regulation	866.3385

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Source

View the full FDA submission: accessdata.fda.gov

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Simple 2 Test

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