Roche Diagnostics Operations (Rdo) - FDA 510(k) Cleared Devices

Cleared Mar 26, 2020

Tina-quant Hemoglobin A1cDx Gen.3

K193053 · PDJ

Chemistry · 146d

Cleared Feb 08, 2019

Ammonia II

K183517 · JIF

Chemistry · 52d

Cleared May 10, 2017

ALP IFCC Gen.2

K171080 · CJE

Chemistry · 29d

Cleared Dec 19, 2016

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

K160571 · PDJ

Chemistry · 294d

Cleared Oct 19, 2016

HDL-Cholesterol Gen.4

K162593 · LBS

Chemistry · 33d

Cleared Jul 27, 2016

Tina-quant Cystatin C Gen.2

K161817 · NDY

Chemistry · 26d

Cleared May 25, 2016

Creatine Kinase

K160570 · JHS

Chemistry · 86d

Cleared Jan 08, 2016

ONLINE TDM Vancomycin Gen.3

K152245 · LEH

Chemistry · 151d

Cleared Jan 28, 2015

LDLC3 LDL-Cholesterol Gen.3

K143691 · LBR

Chemistry · 35d

Cleared Dec 09, 2014

TOTAL PROTEIN URINE/CSF GEN.3

K141925 · JIQ

Chemistry · 146d

Cleared Nov 25, 2014

COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR

K141928 · DKB

Chemistry · 132d