510k
Database
Specialties
Anesthesiology
515
Cardiovascular
1595
Chemistry
356
Dental
1289
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2118
General Hospital
1908
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
933
Obstetrics & Gynecology
423
Ophthalmic
267
Orthopedic
2684
Pathology
52
Physical Medicine
508
Radiology
2302
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
393
LLZ
System, Image Processing,...
361
GEX
Powered Laser Surgical Instrument
348
FXX
Mask, Surgical
301
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Nano-Ditech Corporation
Medical Device Manufacturer
·
US , Cranbury , NJ
Nano-Ditech Corporation - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2010
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nano-Ditech Corporation
Microbiology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 15, 2026
Nano-Check Influenza A+B Test
K252283
·
PSZ
Microbiology
·
177d
Cleared
Jun 17, 2025
Nano-Check Influenza+COVID-19 Dual Test
K243561
·
SCA
Microbiology
·
211d
Cleared
Jul 30, 2024
Nano-Check™ RSV Test
K240280
·
GQG
Microbiology
·
180d
Cleared
Jan 23, 2024
Nano-Check™ COVID-19 Antigen Test
K231187
·
QVF
Microbiology
·
272d
Filters
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6
Microbiology
4
Chemistry
2