Hoffmann-La Roche, Inc.: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “Hoffmann-La Roche, Inc.” (first 1976, latest 1985), across 31 product codes in 4 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 7 | 7 |
| DJP | Radioimmunoassay, Amphetamine | 3 | 3 |
| JSG | Culture Media, Non-Selective And Non-Differential | 3 | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 2 |
| DKN | Radioimmunoassay, Barbiturate | 2 | 2 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 2 | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| KXS | Radioimmunoassay, Methaqualone | 2 | 2 |
| LCL | Radioimmunoassay, Phencyclidine | 2 | 2 |
Plus 21 more product codes.
Review panels
- Clinical Chemistry (27)
- Clinical Toxicology (14)
- Microbiology (5)
- Hematology (1)
Most recent Hoffmann-La Roche, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850727 | BHCG-ROCHE EIA | JHI | 1985-06-25 | 123 |
| K831694 | RENAK | CIB | 1983-07-19 | 56 |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | DJP | 1983-03-24 | 37 |
| K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE | LCL | 1983-03-24 | 37 |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | KLN | 1983-03-24 | 37 |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | DOE | 1983-03-24 | 37 |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | KXS | 1983-03-24 | 37 |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | DOE | 1983-03-24 | 37 |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | DKN | 1983-03-10 | 23 |
| K823580 | COBAS REAGENT FOR INORGANIC PHOSPHORUS | CEO | 1983-01-07 | 32 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hoffmann-La Roche, 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.
Device clinical trials
An industry sponsor named Hoffmann-La Roche, Inc. is the lead sponsor of 56 device studies on ClinicalTrials.gov (14 active or recruiting). Most recent:
- NCT07416526: A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A (Recruiting, started 2026-05-09)
- NCT07416604: A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A (Recruiting, started 2026-04-27)
- NCT07351058: A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes (Recruiting, started 2026-03-23)
- NCT07351045: A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes (Recruiting, started 2026-03-16)
- NCT06847542: A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD (Recruiting, started 2025-11-27)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hoffmann-La Roche, Inc.?
FDA lists 49 510(k) clearances under the applicant name “Hoffmann-La Roche, Inc.” (first 1976, latest 1985), across 31 product codes in 4 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 Hoffmann-La Roche, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hoffmann-La Roche, Inc. is 32 days.
Which FDA product codes appear under Hoffmann-La Roche, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 7); DJP (Radioimmunoassay, Amphetamine, 3); JSG (Culture Media, Non-Selective And Non-Differential, 3).
Next steps
- See all 49 Hoffmann-La Roche, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Hoffmann-La Roche, 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.