Roche Diagnostics - FDA 510(k) Cleared Devices

Cleared Feb 12, 2026

Glucose HK Gen.3

K253490 · CFR

Chemistry · 111d

Cleared Feb 12, 2026

ISE indirect K for Gen.2

K253491 · CEM

Chemistry · 111d

Cleared Jul 17, 2025

Elecsys Cortisol III

K242505 · JFT

Chemistry · 329d

Cleared Feb 07, 2025

Elecsys sFlt-1 and Elecsys PlGF

K241453 · QWH

Chemistry · 261d

Cleared Jun 17, 2024

Elecsys Folate III

K233060 · CGN

Chemistry · 266d

Cleared Apr 26, 2024

cobas pulse blood glucose monitoring system

K220272 · PZI

Chemistry · 816d

Cleared Mar 22, 2024

Elecsys PTH , Elecsys PTH STAT

K231927 · CEW

Chemistry · 266d

Cleared Jul 21, 2023

Elecsys proBNP II, Elecsys proBNP II STAT

K223637 · NBC

Chemistry · 228d

Cleared Apr 07, 2023

Elecsys FT4 IV

K220456 · CEC

Chemistry · 414d

Cleared Mar 30, 2023

ONLINE TDM Phenytoin - Free Phenytoin application

K230161 · MOJ

Chemistry · 69d

Cleared Sep 16, 2022

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...

K220134 · CFR

Chemistry · 241d

Cleared Jun 10, 2022

Elecsys AMH

K203757 · PQO

Chemistry · 534d