Roche Diagnostics Operations (Rdo) - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
Roche Diagnostics Operations (Rdo) has 14 FDA 510(k) cleared chemistry devices. Based in Indianapolos, US.
Historical record: 14 cleared submissions from 2014 to 2020.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Roche Diagnostics Operations (Rdo)
14 devices
Cleared
Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
Chemistry
146d
Cleared
Feb 21, 2020
Tina-quant C-Reactive Protein IV
Immunology
203d
Cleared
Feb 08, 2019
Ammonia II
Chemistry
52d
Cleared
Nov 05, 2018
Tina-quant Transferrin ver.2 (urine application)
Immunology
94d
Cleared
May 10, 2017
ALP IFCC Gen.2
Chemistry
29d
Cleared
Dec 19, 2016
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
Chemistry
294d
Cleared
Oct 19, 2016
HDL-Cholesterol Gen.4
Chemistry
33d
Cleared
Jul 27, 2016
Tina-quant Cystatin C Gen.2
Chemistry
26d
Cleared
May 25, 2016
Creatine Kinase
Chemistry
86d
Cleared
Jan 08, 2016
ONLINE TDM Vancomycin Gen.3
Chemistry
151d
Cleared
Oct 22, 2015
Carbamazepine Gen 4
Toxicology
133d
Cleared
Jan 28, 2015
LDLC3 LDL-Cholesterol Gen.3
Chemistry
35d
Cleared
Dec 09, 2014
TOTAL PROTEIN URINE/CSF GEN.3
Chemistry
146d
Cleared
Nov 25, 2014
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
Chemistry
132d