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..

Clearance details

Applicant: Baebies, Inc.
Product code: Code QOF
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 ↗

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