FINDER Flu A&B/SARS-CoV-2 Test— 510(k) K252269

Substantially Equivalent

Baebies, Inc.

FDA 510(k) clearance K252269 for FINDER Flu A&B/SARS-CoV-2 Test, Substantially Equivalent on 2026-03-30. Applicant: Baebies, Inc.. Device class: 2.

Clearance details

Applicant: Baebies, Inc.
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2025-07-21
Decision date: 2026-03-30
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

K261837 — FINDER Flu A&B/SARS-CoV-2 Test2026-09-11
K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K251742 — VELO Respiratory Test2026-02-13
K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23
K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)2025-10-30

More clearances from Baebies, Inc.

K201049 — FINDER G6PD2022-09-14
DEN150035 — SEEKER System2017-02-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.