Damon Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Damon Corp.” (first 1976, latest 1987), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CKG | Radioimmunoassay, Acth | 1 | 1 |
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (7)
- Hematology (1)
- Radiology (1)
- Clinical Toxicology (1)
Most recent Damon Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874865 | DAMON D.E.T.E.C.T IMAGE ENHANCER | LLZ | 1987-12-23 | 26 |
| K831826 | ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY | CKG | 1983-07-18 | 41 |
| K820686 | LIQUISOL PROGESTERONE RADIOIMMUNO | JLS | 1982-04-01 | 21 |
| K802661 | LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT | CDZ | 1980-12-10 | 43 |
| K790250 | LIQUISOL CORTISOL RIA TEST KIT | — | 1979-04-04 | 57 |
| K782124 | IEC CENTRA-7 CENTRIFUGE MODEL 2362 | JQC | 1979-02-26 | 61 |
| K781012 | RIA TEST KIT SYS. DAMON KIQUISOL FREE | CEC | 1978-07-27 | 41 |
| K780207 | LIQUISOL DIGOXIN RIA TEST KIT | DON | 1978-02-23 | 16 |
| K770918 | LIQUI SOL T4 RIA TEST KIT | CDP | 1977-06-17 | 29 |
| K770606 | ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH | JPA | 1977-05-06 | 36 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Damon Corp..
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 Damon Corp.?
FDA lists 11 510(k) clearances under the applicant name “Damon Corp.” (first 1976, latest 1987), across 10 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 Damon Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Damon Corp. is 36 days.
Which FDA product codes appear under Damon Corp.?
The most frequent FDA product codes under this applicant name are JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 1).
Next steps
- See all 11 Damon Corp. clearances with predicates and recalls
- Run predicate analysis for product code JQC, Damon Corp.'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.