Bionostics, Inc.: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “Bionostics, Inc.” (first 1983, latest 2013), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 40 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 | 1 | 40 |
| 2013 | 3 | 39 |
| 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 22 | 22 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 10 | 10 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 5 | 5 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 2 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 2 | 2 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| GLK | Control, Hematocrit | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (45)
- Hematology (3)
- Clinical Toxicology (1)
Most recent Bionostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131136 | GLUCOSE METER-CHECK SOLUTION FOR TAIDOC | JJX | 2013-05-31 | 39 |
| K123851 | GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK | JJX | 2013-02-14 | 62 |
| K123966 | GLUCOSE METER-CHECK SOLUTION FOR BAYER | JJX | 2013-01-25 | 30 |
| K113764 | GLUCOSE METER-CHECK SOLUTION FOR INFOPIA | JJX | 2012-01-30 | 40 |
| K112352 | GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT | JJX | 2011-12-23 | 129 |
| K112356 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE | JJX | 2011-09-19 | 34 |
| K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION | JJX | 2011-02-10 | 69 |
| K101831 | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 | OSL | 2010-10-01 | 92 |
| K091914 | OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION | JJX | 2009-11-06 | 129 |
| K081478 | RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS | JJX | 2008-10-06 | 132 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bionostics, 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 Bionostics, Inc.?
FDA lists 49 510(k) clearances under the applicant name “Bionostics, Inc.” (first 1983, latest 2013), across 13 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 Bionostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bionostics, Inc. is 40 days.
Which FDA product codes appear under Bionostics, Inc.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 22); JJY (Multi-Analyte Controls, All Kinds (Assayed), 10); JJS (Controls For Blood-Gases, (Assayed And Unassayed), 5).
Next steps
- See all 49 Bionostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Bionostics, 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.