Name: Predicase
Price: 199 USD

K-number	K251595
Device name	COVID-19 Detect Rapid Self -Test
Applicant	InBios International, Inc.
Product code	QYT
Device class	Class II
Decision date	Oct 12, 2025
Decision	Substantially Equivalent
Regulation	866.3984

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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COVID-19 Detect Rapid Self -Test

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