Allergenetics: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Allergenetics” (first 1982, latest 1985), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 46 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 | 3 | 3 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 2 | 2 |
| DGP | Ige, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 | 1 |
Review panels
- Immunology (6)
- Clinical Chemistry (1)
- Clinical Toxicology (1)
Most recent Allergenetics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K851512 | ALLERGENETICS IGE FAST TEST | DHB | 1985-05-28 | 43 |
| K842970 | ALLERGENTICS TOTAL IGE/THEOPHYLLINE | JJY | 1984-08-29 | 30 |
| K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | DGP | 1984-08-28 | 29 |
| K833418 | CHYMOFAST TEST | DHB | 1984-03-12 | 161 |
| K834594 | TOTAL IGE FAST TEST | DGC | 1984-02-10 | 43 |
| K833419 | LABELED 125I ANTI-IGE | DGC | 1984-02-03 | 123 |
| K834244 | THEOFAST TEST KIT FOR QUANTITATIVE THEO | KLS | 1984-01-24 | 48 |
| K822341 | ALLERGENETICS IGE-FAST TEST | DGC | 1982-11-10 | 98 |
Recalls
openFDA lists no recalls under a recalling firm named Allergenetics.
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 Allergenetics?
FDA lists 8 510(k) clearances under the applicant name “Allergenetics” (first 1982, latest 1985), across 5 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 Allergenetics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Allergenetics is 46 days.
Which FDA product codes appear under Allergenetics?
The most frequent FDA product codes under this applicant name are DGC (Ige, Antigen, Antiserum, Control, 3); DHB (System, Test, Radioallergosorbent (Rast) Immunological, 2); DGP (Ige, Fitc, Antigen, Antiserum, Control, 1).
Next steps
- See all 8 Allergenetics clearances with predicates and recalls
- Run predicate analysis for product code DGC, Allergenetics'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.