510k
Database
Specialties
Anesthesiology
133
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
514
General Hospital
371
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
164
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1291
Pathology
18
Physical Medicine
85
Radiology
867
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
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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DNA Genotek, Inc.
Medical Device Manufacturer
·
CA , Ottawa Ontario
DNA Genotek, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
6 cleared
·
Since 2011
7
Total
6
Cleared
1
Denied
FDA 510(k) cleared devices by DNA Genotek, Inc.
Microbiology
✕
1
devices
1-1 of 1
Filters
Not Cleared
Nov 03, 2021
OMNIgene GUT Dx
DEN200040
·
QPO
Microbiology
·
506d
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7
Chemistry
6
Microbiology
1