Nanoentek USA, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nanoentek USA, Inc.” (first 2014, latest 2017), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 260 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 |
|---|---|---|
| 2014 | 1 | 260 |
| 2015 | 0 | — |
| 2016 | 2 | 240 |
| 2017 | 2 | 185 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 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 Nanoentek USA, Inc. took a median 185 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 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 (4)
- Immunology (1)
Most recent Nanoentek USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162378 | FREND PSA PLUS (reagent cartridge) | LTJ | 2017-05-17 | 266 |
| K162754 | FREND Vitamin D Test System | MRG | 2017-01-12 | 104 |
| K153577 | FREND Testosterone Test System | CDZ | 2016-10-14 | 304 |
| K152422 | FREND Free T4 Test System | CEC | 2016-02-17 | 175 |
| K131928 | FREND TSH (REAGENT CARTRIDGE) | JLW | 2014-03-14 | 260 |
Recalls
openFDA lists no recalls under a recalling firm named Nanoentek USA, Inc..
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.
- Nanoentek, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nanoentek USA, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Nanoentek USA, Inc.” (first 2014, latest 2017), across 5 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 Nanoentek USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nanoentek USA, Inc. is 260 days.
Which FDA product codes appear under Nanoentek USA, Inc.?
The most frequent FDA product codes under this applicant name are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 1); CEC (Radioimmunoassay, Free Thyroxine, 1); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 1).
Next steps
- See all 5 Nanoentek USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Nanoentek USA, 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 (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.