Roche Diagnostics Operations (Rdo)
Roche Diagnostics Operations (Rdo) appears in FDA public data with 0 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 26, 2020.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | March 26, 2020 |
| K192072 | Tina-quant C-Reactive Protein IV | February 21, 2020 |
| K183517 | Ammonia II | February 8, 2019 |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | November 5, 2018 |
| K171080 | ALP IFCC Gen.2 | May 10, 2017 |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | December 19, 2016 |
| K162593 | HDL-Cholesterol Gen.4 | October 19, 2016 |
| K161817 | Tina-quant Cystatin C Gen.2 | July 27, 2016 |
| K160570 | Creatine Kinase | May 25, 2016 |
| K152245 | ONLINE TDM Vancomycin Gen.3 | January 8, 2016 |
| K151578 | Carbamazepine Gen 4 | October 22, 2015 |
| K143691 | LDLC3 LDL-Cholesterol Gen.3 | January 28, 2015 |
| K141925 | TOTAL PROTEIN URINE/CSF GEN.3 | December 9, 2014 |
| K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | November 25, 2014 |