Roche Diagnostics Operations - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Roche Diagnostics Operations has 5 FDA 510(k) cleared medical devices. Based in Indianpolis, US.
Latest FDA clearance: Jan 2025. Active since 2012. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Roche Diagnostics Operations Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Roche Diagnostics Operations
5 devices
Cleared
Jan 24, 2025
Tina-quant Lipoprotein(a) Gen.2 Molarity
Chemistry
268d
Cleared
Feb 20, 2024
ONLINE TDM Methotrexate
Toxicology
123d
Cleared
Jul 28, 2017
cobas HbA1c Test, cobas b 101 system
Chemistry
218d
Cleared
Aug 08, 2013
COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
Chemistry
433d
Cleared
May 14, 2012
TINA-QUANT ALBUMIN GEN.2
Toxicology
210d