FDA 510(k)

BioTracker 2.0

N.º K: K253306 · 2026-06-26

Fecha de decisión2026-06-26

Código de producto

DecisiónSubstantially Equivalent

Resumen del dispositivo

BioTracker 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Biotracker, LLC. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K253306. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BioTracker 2.0?

BioTracker 2.0 is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Biotracker, LLC. The 510(k) number is K253306.

When did BioTracker 2.0 receive FDA 510(k) clearance?

BioTracker 2.0 received FDA 510(k) clearance on 2026-06-26, under 510(k) number K253306.

Who is the listed applicant for BioTracker 2.0?

The FDA 510(k) record lists Biotracker, LLC as the applicant. This does not by itself establish the device manufacturer.

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Fuente oficial

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