Name: Predicase
Price: 199 USD

K-number	K251538
Device name	Status COVID-19/Flu A&B
Applicant	Princeton BioMeditech Corp.
Product code	SCA
Device class	Class II
Decision date	Nov 14, 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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Status COVID-19/Flu A&B

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

Status COVID-19/Flu A&B