Qualigen, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Qualigen, Inc.” (first 2000, latest 2019), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 113 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 | 2 | 142 |
| 2014 | 0 | — |
| 2015 | 1 | 198 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 138 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Qualigen, Inc. took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 3 | 3 |
| JIT | Calibrator, Secondary | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 1 | 1 |
| MRG | System, Test, Vitamin D | 1 | 1 |
Review panels
- Clinical Chemistry (13)
- Immunology (2)
Most recent Qualigen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182521 | FastPack IP Sex Hormone Binding Globulin Immunoassay | CDZ | 2019-01-29 | 138 |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit | DCK | 2015-01-07 | 198 |
| K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | MRG | 2013-07-03 | 189 |
| K123725 | FASTPACK CONTROL KIT | JJY | 2013-03-08 | 94 |
| K101388 | FASTPACK TESTO IMMUNOASSAY | CDZ | 2011-02-18 | 277 |
| K101390 | FASTPACK TSH IMMUNOASSAY | JLW | 2010-08-13 | 88 |
| K072264 | FASTPACK HCG IMMUNOASSAY | JHI | 2007-12-06 | 113 |
| K062957 | FASTPACK TOTAL PSA METHOD VERIFICATION KIT | JJX | 2007-04-02 | 185 |
| K052301 | FASTPACK TSH IMMUNOASSAY | JLW | 2006-01-04 | 135 |
| K030329 | FASTPACK FREE T4 IMMUNOASSAY | CEC | 2003-07-03 | 153 |
5 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 7 recall events; 2 initiated in the last five years. Most recent: 2024-12-03.
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 Qualigen, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Qualigen, Inc.” (first 2000, latest 2019), across 10 product codes in 2 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 Qualigen, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Qualigen, Inc. is 113 days.
Which FDA product codes appear under Qualigen, Inc.?
The most frequent FDA product codes under this applicant name are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 3); JIT (Calibrator, Secondary, 2); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2).
Next steps
- See all 15 Qualigen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Qualigen, Inc.'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.