Biotrol, USA, Inc.: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Biotrol, USA, Inc.” (first 1987, latest 1995), across 33 product codes in 3 review panels. 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 5 | 5 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 4 | 4 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CIJ | Saccharogenic, Amylase | 2 | 2 |
| JGJ | Photometric Method, Magnesium | 2 | 2 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 2 | 2 |
| JIS | Calibrator, Primary | 2 | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
Plus 23 more product codes.
Review panels
- Clinical Chemistry (42)
- Microbiology (3)
- General Hospital (1)
Most recent Biotrol, USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934014 | VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT | LRJ | 1995-12-06 | 841 |
| K931141 | BIOTROL AMYLASE CNPG3 | CIJ | 1993-05-26 | 82 |
| K921855 | BIOTROL BICARBONATE STANDARDS | JIS | 1992-08-03 | 108 |
| K921677 | BIOTROL MAGNESIUM (MAGON) | JGJ | 1992-05-26 | 48 |
| K912795 | BIOTROL UIBC REAGENT | JMO | 1991-08-12 | 48 |
| K910721 | BIOTROL PROTEIN MULTILEVEL STANDARDS | JIS | 1991-05-06 | 75 |
| K905683 | BIOTROL LACTATE DEHYDROGENASE (L-P) | CFJ | 1991-03-11 | 82 |
| K905280 | BIOTROL BILIRUBIN C & T CONTROL | JJX | 1991-02-04 | 73 |
| K894544 | BIOTROL RUB-E.I.A. TEST G | LFX | 1989-08-30 | 41 |
| K891061 | BIOTROL CALCIUM MONOREACTIF | CJY | 1989-08-10 | 162 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biotrol, USA, 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 Biotrol, USA, Inc.?
FDA lists 46 510(k) clearances under the applicant name “Biotrol, USA, Inc.” (first 1987, latest 1995), across 33 product codes in 3 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 Biotrol, USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotrol, USA, Inc. is 43 days.
Which FDA product codes appear under Biotrol, USA, Inc.?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 5); JJY (Multi-Analyte Controls, All Kinds (Assayed), 4); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2).
Next steps
- See all 46 Biotrol, USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIX, Biotrol, USA, 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.