Biotope, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Biotope, Inc.” (first 1991, latest 1991), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Review panels
Most recent Biotope, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905145 | ECLIPSE ICA CHOLESTEROL | CHH | 1991-02-26 | 103 |
| K910302 | ECLIPSE ICA ANALYZER | JJQ | 1991-02-22 | 29 |
| K910256 | ECLIPSE ICA TSH | JLW | 1991-02-22 | 31 |
| K905719 | ECLIPSE ICA DIGOXIN | DPO | 1991-01-17 | 27 |
| K905601 | ECLIPSE ICA TRIGLYCERIDES | CDT | 1991-01-17 | 35 |
| K905602 | ECLIPSE ICA BUN | CDQ | 1991-01-16 | 34 |
| K905144 | ECLIPSE ICA GLUCOSE | CFR | 1991-01-04 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Biotope, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotope, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Biotope, Inc.” (first 1991, latest 1991), across 7 product codes in 2 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 Biotope, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotope, Inc. is 34 days.
Which FDA product codes appear under Biotope, Inc.?
The most frequent FDA product codes under this applicant name are CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1); CFR (Hexokinase, Glucose, 1).
Next steps
- See all 7 Biotope, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDQ, Biotope, 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.