Roche Analytical Instruments, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Roche Analytical Instruments, Inc.” (first 1980, latest 1980), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (11)
Most recent Roche Analytical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K801299 | COBAS CK-NAC REAGENT | CGS | 1980-07-14 | 42 |
| K801298 | COBAS REAGENT FOR TRIGLYCERIDES & COBAS | CDT | 1980-07-08 | 36 |
| K801295 | COBAS REAGENT FOR A-AMYLASE | JFJ | 1980-07-08 | 36 |
| K801297 | COBAS REAGENT FOR GLUCOSE RAPID | CFR | 1980-06-30 | 28 |
| K801296 | COBAS REAGENT FOR CHOLESTEROL | CHH | 1980-06-30 | 28 |
| K801243 | COBAS REAGENTS FOR URIC ACID | CDO | 1980-06-26 | 30 |
| K801242 | COBAS REAGENT FOR ALKALINE PHOSPHATASE | CJE | 1980-06-20 | 24 |
| K801118 | COBAS REAGENT FOR AST (SGOT) | CIT | 1980-06-20 | 39 |
| K801116 | COBAS REAGENT FOR BUN | CDQ | 1980-06-17 | 36 |
| K801119 | COBAS REAGENT FOR ALT (GPT) | CKA | 1980-06-09 | 28 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Roche Analytical Instruments, 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. (451 510(k)s)
- Roche Diagnostic Systems, Inc. (296 510(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. (10 510(k)s)
- Roche Diagnostics Operations (7 510(k)s)
- Roche Diagnostics GmbH (5 510(k)s)
- Roche Diagnostics/Boehringer Mannheim GmbH (3 510(k)s)
- Roche (2 510(k)s)
- Roche Diabetes Care GmbH (2 510(k)s)
- Roche Professional Diagnostics (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Roche Analytical Instruments, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Roche Analytical Instruments, Inc.” (first 1980, latest 1980), across 11 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Roche Analytical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Roche Analytical Instruments, Inc. is 30 days.
Which FDA product codes appear under Roche Analytical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are CDO (Acid, Uric, Uricase (U.V.), 1); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Next steps
- See all 11 Roche Analytical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDO, Roche Analytical Instruments, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.