Nano-Ditech Corporation
Cranbury, NJ, US
NANO-DITECH CORPORATION appears in FDA device records in Cranbury, NJ. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Nano-Ditech Corporation between 2005 and 2026. The busiest year on record is 2010, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2010 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252283 | Nano-Check Influenza A+B Test | PSZ | Substantially Equivalent | |
| K243561 | Nano-Check Influenza+COVID-19 Dual Test | SCA | Substantially Equivalent | |
| K240280 | Nano-Check™ RSV Test | GQG | Substantially Equivalent | |
| K231187 | Nano-Check™ COVID-19 Antigen Test | QVF | Substantially Equivalent | |
| K102441 | NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN | MMI | Substantially Equivalent | |
| K102131 | NANO-CHECK AMI CTNI CARDIAC MARKER TEST | MMI | Substantially Equivalent | |
| K050975 | NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN | MMI | Substantially Equivalent | |
| K050594 | NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE | LDJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005174594 | 3005174594 | NANO-DITECH CORPORATION | 259 Prospect Plains Rd Bldg K, Cranbury, NJ 08512 US | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- NTMAntigen, Inflammatory Response Marker, Sepsis
- JRGBlock, Heating
- JHTChromatographic Separation, Cpk Isoenzymes
- QMNCovid-19 Multi-Analyte Antigen Device
- QLWCovid-19 Test Home Collection Kit Devices
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- KHOFluorometer, For Clinical Use
- LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
- MMIImmunoassay Method, Troponin Subunit
- MJZKit, Direct Antigen, Positive Control
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test
- DDRMyoglobin, Antigen, Antiserum, Control
- KHEReagent, Occult Blood
- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- DCNSystem, Test, C-Reactive Protein
- MRGSystem, Test, Vitamin D
- NBCTest, Natriuretic Peptide
- DJCThin Layer Chromatography, Methamphetamine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain