United Biotech, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “United Biotech, Inc.” (first 1985, latest 1998), across 19 product codes in 4 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 3 | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (10)
- Immunology (6)
- Clinical Toxicology (4)
- Microbiology (2)
Most recent United Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981573 | UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE | JFH | 1998-09-15 | 134 |
| K973154 | UBI MAGIWEL MARIJUANA METABOLITES | LDJ | 1998-07-22 | 334 |
| K973692 | UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE | DCK | 1998-02-09 | 136 |
| K973156 | UBI MAGIWEL COCAINE METABOLITES | DJG | 1997-10-28 | 67 |
| K973155 | UBI MAGIWEL OPIATE METABOLITES | DJG | 1997-10-28 | 67 |
| K973153 | UBI MAGIWEL AMPHETAMINE METABOLITES | DJG | 1997-10-28 | 67 |
| K962211 | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE | KLI | 1996-07-08 | 28 |
| K961236 | UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE | CDP | 1996-05-30 | 62 |
| K951993 | UBI MAGIWEL FERRITIN QUANTITATIVE | DBF | 1995-07-05 | 68 |
| K924689 | UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG | LYR | 1993-08-10 | 327 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named United Biotech, 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.
- United States Surgical, A Division of Tyco Healthc (218 510(k)s)
- United States Endoscopy Group, Inc. (94 510(k)s)
- United Orthopedic Corporation (61 510(k)s)
- United Consortium (15 510(k)s)
- United Diagnostics, Inc. (12 510(k)s)
- United Medical Industries Co. , Ltd. (10 510(k)s)
- United Surgical Corp. (7 510(k)s)
- United Dental Mfg., Inc. (5 510(k)s)
- United Medical Systems, Inc. (5 510(k)s)
- United Pacific Co., Ltd. (5 510(k)s)
- United Sonics, Inc. (5 510(k)s)
- United Medical (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under United Biotech, Inc.?
FDA lists 22 510(k) clearances under the applicant name “United Biotech, Inc.” (first 1985, latest 1998), across 19 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 United Biotech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name United Biotech, Inc. is 64 days.
Which FDA product codes appear under United Biotech, Inc.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 3); JHI (Visual, Pregnancy Hcg, Prescription Use, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1).
Next steps
- See all 22 United Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DJG, United Biotech, 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.