510k
Database
Specialties
Anesthesiology
135
Cardiovascular
569
Chemistry
165
Dental
318
Ear, Nose, Throat
68
Gastroenterology & Urology
290
General & Plastic Surgery
526
General Hospital
377
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
62
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51
Orthopedic
1296
Pathology
18
Physical Medicine
87
Radiology
872
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Kronus, Inc.
Medical Device Manufacturer
·
US , Star , ID
Kronus, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
4 cleared
·
Since 2016
5
Total
4
Cleared
1
Denied
FDA 510(k) cleared devices by Kronus, Inc.
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 24, 2023
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K220085
·
OIF
Chemistry
·
590d
Cleared
Jan 19, 2018
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K171731
·
OIF
Chemistry
·
221d
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5
Immunology
3
Chemistry
2