Diamedix Corp.: FDA filings under this applicant name
FDA lists 68 510(k) clearances under the applicant name “Diamedix Corp.” (first 1986, latest 2011), across 33 product codes in 4 review panels. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 10 | 10 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 | 5 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 4 | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 4 | 4 |
| DHR | System, Test, Rheumatoid Factor | 3 | 3 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 3 | 3 |
| MID | System, Test, Anticardiolipin Immunological | 3 | 3 |
| CZW | Complement C3, Antigen, Antiserum, Control | 2 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 2 | 2 |
Plus 23 more product codes.
Review panels
- Immunology (34)
- Microbiology (28)
- Clinical Chemistry (5)
- Hematology (1)
Most recent Diamedix Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093101 | MAGO 4S | LFX | 2011-01-21 | 477 |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | DHR | 2002-07-09 | 68 |
| K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN | MSV | 2002-01-08 | 39 |
| K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM | MSV | 2001-12-21 | 46 |
| K012450 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM | MID | 2001-10-26 | 86 |
| K012449 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM | MID | 2001-10-26 | 86 |
| K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM | MST | 2001-09-28 | 38 |
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM | MST | 2001-09-28 | 38 |
| K012053 | DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM | MID | 2001-08-20 | 49 |
| K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | LGC | 2000-11-28 | 126 |
58 earlier clearances. See the full list in Caduvo.
Recalls
14 product recalls in 11 recall events; 0 initiated in the last five years. Most recent: 2018-01-05.
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 Diamedix Corp.?
FDA lists 68 510(k) clearances under the applicant name “Diamedix Corp.” (first 1986, latest 2011), across 33 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 Diamedix Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diamedix Corp. is 66 days.
Which FDA product codes appear under Diamedix Corp.?
The most frequent FDA product codes under this applicant name are LLL (Extractable Antinuclear Antibody, Antigen And Control, 10); LFX (Enzyme Linked Immunoabsorbent Assay, Rubella, 5); LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, 4).
Next steps
- See all 68 Diamedix Corp. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Diamedix 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.