Immunotech Corp.: FDA filings under this applicant name
FDA lists 40 510(k) clearances under the applicant name “Immunotech Corp.” (first 1980, latest 1995), across 26 product codes in 3 review panels. Median 510(k) review time under this name: 63 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.
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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 6 | 6 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 2 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 2 | 2 |
| CGI | Radioimmunoassay, Estriol | 2 | 2 |
| KLS | Enzyme Immunoassay, Theophylline | 2 | 2 |
| KXT | Enzyme Immunoassay, Digoxin | 2 | 2 |
| CDA | Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
Plus 16 more product codes.
Review panels
- Clinical Chemistry (21)
- Clinical Toxicology (13)
- Hematology (6)
Most recent Immunotech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954188 | OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL | GKZ | 1995-11-03 | 58 |
| K946335 | OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES | GKZ | 1995-10-20 | 295 |
| K953498 | OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL | GKZ | 1995-09-08 | 44 |
| K952789 | OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES | GKZ | 1995-08-14 | 56 |
| K952182 | OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES | GKZ | 1995-07-05 | 57 |
| K950626 | OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES | GKZ | 1995-05-05 | 84 |
| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | JLS | 1993-10-22 | 226 |
| K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST | CEC | 1991-06-24 | 74 |
| K911153 | MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT | LCM | 1991-06-18 | 95 |
| K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT | JLW | 1991-04-03 | 64 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immunotech 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.
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.
- Immunotech S.A. (1 510(k)s)
- Immunotech S.R.O. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Immunotech Corp.?
FDA lists 40 510(k) clearances under the applicant name “Immunotech Corp.” (first 1980, latest 1995), across 26 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 Immunotech Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immunotech Corp. is 63 days.
Which FDA product codes appear under Immunotech Corp.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 6); CDP (Radioimmunoassay, Total Triiodothyronine, 3); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 3).
Next steps
- See all 40 Immunotech Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Immunotech 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.