Scientific Distributors, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Scientific Distributors, Inc.” (first 1984, latest 1989), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| GIF | Diluent, Blood Cell | 4 | 4 |
| JCG | Fluid, Diluting, Manual Cell | 1 | 1 |
| JJO | Flame Emission Photometer For Clinical Use | 1 | 1 |
Plus 1 more product codes.
Review panels
- Hematology (5)
- Clinical Chemistry (1)
Most recent Scientific Distributors, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892658 | SDI PREPAX COUNTAPETTE KIT | JCG | 1989-05-24 | 41 |
| K851320 | SDI PREPAX DILUKIT M. | GIF | 1985-07-05 | 94 |
| K840044 | SDI PREPAX DILUKIT 29-1000 | JJO | 1984-03-09 | 63 |
| K840041 | SDI PREPAX DILUKIT HW | GIF | 1984-03-05 | 59 |
| K840043 | SDI PREPAX DILUKIT CT | GIF | 1984-02-10 | 35 |
| K840042 | SDI PREPAX DILUKIT CA | — | 1984-02-10 | 35 |
| K840038 | PREPAX DILUKIT PLUS | GIF | 1984-02-10 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Scientific Distributors, 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.
- Scientific Pharmaceuticals, Inc. (73 510(k)s)
- Scientific Device Laboratory, Inc. (28 510(k)s)
- Scientific Sales Intl., Inc. (11 510(k)s)
- Scientific Device Manufacturer, LLC (6 510(k)s)
- Scientific Research (5 510(k)s)
- Scientific Imaging, Inc. (3 510(k)s)
- Scientific Specialties, Inc. (3 510(k)s)
- Scientific & General Pty. , Ltd. (2 510(k)s)
- Scientific Manufacturing Industries (2 510(k)s)
- Scientific Spinal , Ltd. (2 510(k)s)
- Scientific Standards, Inc. (2 510(k)s)
- Scientific Technology , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scientific Distributors, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Scientific Distributors, Inc.” (first 1984, latest 1989), across 4 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 Scientific Distributors, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scientific Distributors, Inc. is 41 days.
Which FDA product codes appear under Scientific Distributors, Inc.?
The most frequent FDA product codes under this applicant name are GIF (Diluent, Blood Cell, 4); JCG (Fluid, Diluting, Manual Cell, 1); JJO (Flame Emission Photometer For Clinical Use, 1).
Next steps
- See all 7 Scientific Distributors, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GIF, Scientific Distributors, 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.