Nano-Ditech Corporation: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Nano-Ditech Corporation” (first 2005, latest 2026), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 178 days. Since 2017 the median was 196 days, against 179 days for all cleared 510(k)s in the same product codes. 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 | 2 | 226 |
| 2025 | 1 | 211 |
| 2026 | 1 | 177 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nano-Ditech Corporation took a median 196 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 179 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | 3 | 3 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 1 | 1 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 1 | 1 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 1 | 1 |
Review panels
Most recent Nano-Ditech Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252283 | Nano-Check Influenza A+B Test | PSZ | 2026-01-15 | 177 |
| K243561 | Nano-Check Influenza+COVID-19 Dual Test | SCA | 2025-06-17 | 211 |
| K240280 | Nano-Check RSV Test | GQG | 2024-07-30 | 180 |
| K231187 | Nano-Check COVID-19 Antigen Test | QVF | 2024-01-23 | 272 |
| K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN | MMI | 2010-10-20 | 83 |
| K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST | MMI | 2010-10-20 | 83 |
| K050975 | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN | MMI | 2006-03-02 | 318 |
| K050594 | NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE | LDJ | 2005-05-15 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Nano-Ditech Corporation.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Nano-Ditech Corporation (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Nano-Ditech Corporation?
FDA lists 8 510(k) clearances under the applicant name “Nano-Ditech Corporation” (first 2005, latest 2026), across 6 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 Nano-Ditech Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nano-Ditech Corporation is 178 days. Since 2017: 196 days, versus 179 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nano-Ditech Corporation?
The most frequent FDA product codes under this applicant name are MMI (Immunoassay Method, Troponin Subunit, 3); GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, 1); LDJ (Enzyme Immunoassay, Cannabinoids, 1).
Next steps
- See all 8 Nano-Ditech Corporation clearances with predicates and recalls
- Run predicate analysis for product code MMI, Nano-Ditech Corporation'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.