Company · US
Nano-Ditech Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | 3 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 1 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 1 |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2026 | K252283 | Nano-Check Influenza A+B Test Nano-Ditech Corporation | PSZ |
| Jun 17, 2025 | K243561 | Nano-Check Influenza+COVID-19 Dual Test Nano-Ditech Corporation | SCA |
| Jul 30, 2024 | K240280 | Nano-Check RSV Test Nano-Ditech Corporation | GQG |
| Jan 23, 2024 | K231187 | Nano-Check COVID-19 Antigen Test Nano-Ditech Corporation | QVF |
| Oct 20, 2010 | K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN Nano-Ditech Corporation | MMI |
| Oct 20, 2010 | K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST Nano-Ditech Corporation | MMI |
| Mar 2, 2006 | K050975 | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN Nano-Ditech Co. | MMI |
| May 15, 2005 | K050594 | NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE Nano-Ditech Co. | LDJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||