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FDA 510(k)

FINDER Flu A&B/SARS-CoV-2 Test

K-Number: K252269 · 2026-03-30

ApplicantBaebies, Inc.
Decision Date2026-03-30
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FINDER Flu A&B/SARS-CoV-2 Test is a medical device manufactured by Baebies, Inc.. It received FDA 510(k) clearance on 2026-03-30 under approval number K252269. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINDER Flu A&B/SARS-CoV-2 Test?

FINDER Flu A&B/SARS-CoV-2 Test is a medical device that received FDA 510(k) clearance on 2026-03-30. It is manufactured by Baebies, Inc.. The 510(k) number is K252269.

When was FINDER Flu A&B/SARS-CoV-2 Test approved by the FDA?

FINDER Flu A&B/SARS-CoV-2 Test received FDA 510(k) clearance on 2026-03-30, under approval number K252269.

What company makes FINDER Flu A&B/SARS-CoV-2 Test?

FINDER Flu A&B/SARS-CoV-2 Test is manufactured by Baebies, Inc..

What is the FDA product code for FINDER Flu A&B/SARS-CoV-2 Test?

The FDA product code for FINDER Flu A&B/SARS-CoV-2 Test is QOF.

Other Devices by Baebies, Inc.

Related Devices (Code: QOF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.