Dr. Bruno Lange GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dr. Bruno Lange GmbH” (first 1980, latest 1984), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 43 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 4 | 4 |
| JJO | Flame Emission Photometer For Clinical Use | 1 | 1 |
Review panels
Most recent Dr. Bruno Lange GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K834226 | FLAME PHOTOMETERS | JJO | 1984-06-22 | 199 |
| K832531 | PHOTOMETER LP 300 | JJQ | 1983-12-12 | 136 |
| K801564 | PHOTOMETER LP 1 | JJQ | 1980-08-20 | 43 |
| K801563 | PHOTOMETER LP 3 | JJQ | 1980-08-20 | 43 |
| K801562 | PHOTOMETER LP 6 | JJQ | 1980-08-20 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Dr. Bruno Lange GmbH.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dr. Bruno Lange GmbH?
FDA lists 5 510(k) clearances under the applicant name “Dr. Bruno Lange GmbH” (first 1980, latest 1984), across 2 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 Dr. Bruno Lange GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dr. Bruno Lange GmbH is 43 days.
Which FDA product codes appear under Dr. Bruno Lange GmbH?
The most frequent FDA product codes under this applicant name are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 4); JJO (Flame Emission Photometer For Clinical Use, 1).
Next steps
- See all 5 Dr. Bruno Lange GmbH clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Dr. Bruno Lange GmbH'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.