Bioscientific: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Bioscientific” (first 1978, latest 1981), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| HZJ | Stain, Papanicolau | 3 | 3 |
| JPK | Mixture, Hematology Quality Control | 3 | 3 |
| HYI | Iodine, Grams | 1 | 1 |
| HYK | Hematoxylin Harris'S | 1 | 1 |
| IAF | Wright'S Stain | 1 | 1 |
| JCC | Ph Buffer | 1 | 1 |
| JTS | Stains, Microbiologic | 1 | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 | 1 |
| KHM | Nephelometric, Amylase | 1 | 1 |
| KQC | Stains, Hematology | 1 | 1 |
Plus 1 more product codes.
Review panels
- Pathology (8)
- Hematology (4)
- Clinical Chemistry (1)
- Microbiology (1)
Most recent Bioscientific 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812447 | AMYLASE REAGENT KIT | KHM | 1981-09-09 | 12 |
| K811251 | CITRATE BUFFER | JCC | 1981-05-21 | 16 |
| K801268 | HEMOGLOBIN CONTROL LEVELS | KHG | 1980-07-14 | 47 |
| K801267 | RED BLOOD CELL COUNT & HEMATOCRIT CNTL | JPK | 1980-07-14 | 47 |
| K801265 | WHITE BLOOD CELL COUNT CONTROL LEVELS | JPK | 1980-07-14 | 47 |
| K791658 | WRIGHT STAIN PACK | — | 1979-10-17 | 57 |
| K791007 | STAT DIFF STAIN | KQC | 1979-08-03 | 64 |
| K790415 | HCP-7 | JPK | 1979-04-04 | 37 |
| K781734 | SODIUM CHLORIDE, 0.85% | — | 1978-10-24 | 12 |
| K781588 | PAPANICOLAOU STIAN OG-6 | HZJ | 1978-10-10 | 22 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bioscientific.
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 Bioscientific?
FDA lists 16 510(k) clearances under the applicant name “Bioscientific” (first 1978, latest 1981), across 11 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 Bioscientific?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioscientific is 22 days.
Which FDA product codes appear under Bioscientific?
The most frequent FDA product codes under this applicant name are HZJ (Stain, Papanicolau, 3); JPK (Mixture, Hematology Quality Control, 3); HYI (Iodine, Grams, 1).
Next steps
- See all 16 Bioscientific clearances with predicates and recalls
- Run predicate analysis for product code HZJ, Bioscientific'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.