David A. Fuccillo, Ph.D.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “David A. Fuccillo, Ph.D.” (first 1994, latest 1994), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 174 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 4 | 4 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 4 | 4 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
Review panels
- Immunology (9)
Most recent David A. Fuccillo, Ph.D. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935413 | ENA EIA TEST KIT | LLL | 1994-06-02 | 205 |
| K935419 | LA EIA TEST KIT | LLL | 1994-05-05 | 177 |
| K935418 | SCL-70 EIA TEST KIT | LLL | 1994-05-05 | 177 |
| K935417 | JO-1 EIA TEST KIT | LLL | 1994-05-05 | 177 |
| K940251 | MITOCHONDRIA EIA TEST KIT | DBM | 1994-05-03 | 104 |
| K940253 | HISTONE EIA TEST KIT | LJM | 1994-05-02 | 103 |
| K935416 | RO EIA TEST KIT | LJM | 1994-05-02 | 174 |
| K935415 | RNP EIA TEST KIT | LJM | 1994-05-02 | 174 |
| K935414 | SM EIA TEST KIT | LJM | 1994-05-02 | 174 |
Recalls
openFDA lists no recalls under a recalling firm named David A. Fuccillo, Ph.D..
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.
- David Simmonds Co., Inc. (3 510(k)s)
- David Bull Laboratories, USA, Inc. (2 510(k)s)
- David Ayres Medical Co. (1 510(k)s)
- David C. Bishop, Ph.D. (1 510(k)s)
- David Clark Company, Inc. (1 510(k)s)
- David Connell (1 510(k)s)
- David Cott Co. (1 510(k)s)
- David Craig Marketing, Inc. (1 510(k)s)
- David F. Trungale (1 510(k)s)
- David Hendricks, C.P.O. (1 510(k)s)
- David J. Slutsky MD (1 510(k)s)
- David Medical Products Co.,Ltd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under David A. Fuccillo, Ph.D.?
FDA lists 9 510(k) clearances under the applicant name “David A. Fuccillo, Ph.D.” (first 1994, latest 1994), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by David A. Fuccillo, Ph.D.?
The median time from FDA receipt to decision across 510(k)s cleared under the name David A. Fuccillo, Ph.D. is 174 days.
Which FDA product codes appear under David A. Fuccillo, Ph.D.?
The most frequent FDA product codes under this applicant name are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 4); LLL (Extractable Antinuclear Antibody, Antigen And Control, 4); DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control, 1).
Next steps
- See all 9 David A. Fuccillo, Ph.D. clearances with predicates and recalls
- Run predicate analysis for product code LJM, David A. Fuccillo, Ph.D.'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.