Roche Diagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 296 510(k) clearances under the applicant name “Roche Diagnostic Systems, Inc.” (first 1983, latest 1999), across 118 product codes in 6 review panels. Median 510(k) review time under this name: 66 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Roche Diagnostics, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 17 | 17 |
| DIF | Drug Mixture Control Materials | 14 | 14 |
| LAS | Drug Specific Control Materials | 14 | 14 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 11 | 11 |
| DKB | Calibrators, Drug Mixture | 10 | 10 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 9 | 9 |
| JIX | Calibrator, Multi-Analyte Mixture | 9 | 9 |
| DLJ | Calibrators, Drug Specific | 8 | 8 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 7 | 7 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 6 | 6 |
Plus 108 more product codes.
Review panels
- Clinical Toxicology (167)
- Clinical Chemistry (111)
- Hematology (7)
- Immunology (5)
- Microbiology (5)
- Neurology (1)
Most recent Roche Diagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | DIS | 1999-05-03 | 194 |
| K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | JXM | 1999-02-11 | 113 |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | JCM | 1999-02-10 | 112 |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | DLJ | 1998-12-15 | 63 |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | DLJ | 1998-12-15 | 63 |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | DJR | 1998-12-11 | 51 |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | LDJ | 1998-12-11 | 51 |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | JXN | 1998-12-11 | 51 |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | DKZ | 1998-12-11 | 51 |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | DIO | 1998-12-11 | 51 |
286 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Roche Diagnostic Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Roche Diagnostics Corp. (456 510(k)s)
- Roche Molecular Systems, Inc. (52 510(k)s)
- Roche Medical Electronics, Inc. (16 510(k)s)
- Roche Diagnostics Operations (Rdo) (14 510(k)s)
- Roche Diabetes Care, Inc. (12 510(k)s)
- Roche Analytical Instruments, Inc. (11 510(k)s)
- Roche Diagnostics Operations (7 510(k)s)
- Roche Diagnostics/Boehringer Mannheim GmbH (3 510(k)s)
- Roche (2 510(k)s)
- Roche Professional Diagnostics (2 510(k)s)
- Roche Diabetes Care AG (1 510(k)s)
- Roche Diagnostics Hematology, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roche Diagnostic Systems, Inc.?
FDA lists 296 510(k) clearances under the applicant name “Roche Diagnostic Systems, Inc.” (first 1983, latest 1999), across 118 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Roche Diagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roche Diagnostic Systems, Inc. is 66 days.
Which FDA product codes appear under Roche Diagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are DKZ (Enzyme Immunoassay, Amphetamine, 17); DIF (Drug Mixture Control Materials, 14); LAS (Drug Specific Control Materials, 14).
Next steps
- See all 296 Roche Diagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Roche Diagnostic Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.