K-number	K231187
Device name	Nano-Check COVID-19 Antigen Test
Applicant	Nano-Ditech Corporation
Product code	QVF
Device class	Class II
Decision date	Jan 23, 2024
Decision	Substantially Equivalent
Regulation	866.3982

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Source

View the full FDA submission: accessdata.fda.gov

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Nano-Check COVID-19 Antigen Test

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

Nano-Check COVID-19 Antigen Test