Roche Diagnostics Operations (Rdo)
Indianapolis, IN, US
Roche Diagnostics Operations (Rdo) appears in FDA device records in Indianapolis, IN. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Roche Diagnostics Operations (Rdo) between 2014 and 2020. The busiest year on record is 2016, with 5. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 5 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | PDJ | Substantially Equivalent | |
| K192072 | Tina-quant C-Reactive Protein IV | DCN | Substantially Equivalent | |
| K183517 | Ammonia II | JIF | Substantially Equivalent | |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | DDG | Substantially Equivalent | |
| K171080 | ALP IFCC Gen.2 | CJE | Substantially Equivalent | |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | PDJ | Substantially Equivalent | |
| K162593 | HDL-Cholesterol Gen.4 | LBS | Substantially Equivalent | |
| K161817 | Tina-quant Cystatin C Gen.2 | NDY | Substantially Equivalent | |
| K160570 | Creatine Kinase | JHS | Substantially Equivalent | |
| K152245 | ONLINE TDM Vancomycin Gen.3 | LEH | Substantially Equivalent | |
| K151578 | Carbamazepine Gen 4 | KLT | Substantially Equivalent | |
| K143691 | LDLC3 LDL-Cholesterol Gen.3 | LBR | Substantially Equivalent | |
| K141925 | TOTAL PROTEIN URINE/CSF GEN.3 | JIQ | Substantially Equivalent | |
| K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | DKB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DKBCalibrators, Drug Mixture
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- JIFEnzymatic Method, Ammonia
- KLTEnzyme Immunoassay, Carbamazepine
- PDJHemoglobin A1c Test System
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- LBRLdl & Vldl Precipitation, Hdl
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- LEHRadioimmunoassay, Vancomycin
- DCNSystem, Test, C-Reactive Protein
- NDYTest, Cystatin C
- DDGTransferrin, Antigen, Antiserum, Control
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain