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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252269

by Baebies, Inc.

Identifiers

510(k) Number
K252269 FDA 510(k)
FDA Product Code
QOF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3981 FDA 510(k)
Regulation Number
866.3981 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

FINDER Flu A&B/SARS-CoV-2 Test by Baebies, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Baebies, Inc.

Sources (1)

  • FDA 510(k) K252269 24 fields · synced Jun 18, 2026