Scientific Research: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Scientific Research” (first 1984, latest 1991), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 115 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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | 2 | 2 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 1 | 1 |
Review panels
- Immunology (2)
- Microbiology (2)
- Orthopedic (1)
Most recent Scientific Research 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912420 | ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM | HSB | 1991-09-23 | 115 |
| K843077 | ELISA FOR HERPES SIMPLEX VIRUS | LGC | 1985-06-21 | 319 |
| K842887 | HERPES VIRUS AGGLUTINATION TEST | GQO | 1985-02-26 | 218 |
| K843369 | AGGLUTINATION TEST FOR TOTAL IGE | DGC | 1984-11-14 | 78 |
| K843710 | ELISA FOR TOTAL IGE | DGC | 1984-10-22 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Scientific Research.
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 Distributors, Inc. (7 510(k)s)
- Scientific Device Manufacturer, LLC (6 510(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 Research?
FDA lists 5 510(k) clearances under the applicant name “Scientific Research” (first 1984, latest 1991), across 4 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 Scientific Research?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scientific Research is 115 days.
Which FDA product codes appear under Scientific Research?
The most frequent FDA product codes under this applicant name are DGC (Ige, Antigen, Antiserum, Control, 2); GQO (Antisera, Cf, Herpesvirus Hominis 1,2, 1); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Next steps
- See all 5 Scientific Research clearances with predicates and recalls
- Run predicate analysis for product code DGC, Scientific Research'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.