510k
Database
Specialties
Anesthesiology
1012
Cardiovascular
4317
Chemistry
3203
Dental
2741
Ear, Nose, Throat
464
Gastroenterology & Urology
2296
General & Plastic Surgery
3920
General Hospital
3566
Hematology
779
Immunology
774
Medical Genetics
15
Microbiology
1404
Neurology
1755
Obstetrics & Gynecology
853
Ophthalmic
492
Orthopedic
7527
Pathology
163
Physical Medicine
958
Radiology
4601
Toxicology
1235
Categories
LLZ
System, Image Processing,...
725
HRS
Plate, Fixation, Bone
689
GEI
Electrosurgical, Cutting &...
558
IYN
System, Imaging, Pulsed Doppler,...
533
GEX
Powered Laser Surgical Instrument
519
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
461
MAX
Intervertebral Fusion Device...
403
FXX
Mask, Surgical
400
HWC
Screw, Fixation, Bone
392
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
Home
Manufacturers
US
Neo-Genesis
Medical Device Manufacturer
·
US , Portland , OR
Neo-Genesis - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2007
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neo-Genesis
Chemistry
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 13, 2007
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
K060452
·
JLX
Chemistry
·
385d
Filters
Filter by Specialty
All
1
Chemistry
1