Name: Predicase
Price: 199 USD

K-number	K251749
Device name	Flowflex Plus RSV + Flu A/B + COVID Home Test
Applicant	ACON Laboratories, Inc.
Product code	SCA
Device class	Class II
Decision date	Oct 22, 2025
Decision	Substantially Equivalent
Regulation	866.3987

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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Flowflex Plus RSV + Flu A/B + COVID Home Test

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