510k
Database
Specialties
Anesthesiology
206
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741
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187
Dental
472
Ear, Nose, Throat
92
Gastroenterology & Urology
398
General & Plastic Surgery
779
General Hospital
478
Hematology
77
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64
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1
Microbiology
277
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308
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121
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81
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1481
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26
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155
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1101
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94
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
127
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
113
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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About
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Genepoc, Inc.
Medical Device Manufacturer
·
CA , Quebec
Genepoc, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2017
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Genepoc, Inc.
Microbiology
✕
5
devices
1-5 of 5
Filters
Cleared
May 10, 2019
GenePOC Carba
K190275
·
PMY
Microbiology
·
91d
Cleared
Mar 06, 2019
GenePOC Strep A
K183366
·
PGX
Microbiology
·
92d
Cleared
Nov 22, 2017
GenePOC CDiff
K172569
·
OZN
Microbiology
·
89d
Cleared
May 25, 2017
GenePOC GBS LB
K170557
·
NJR
Microbiology
·
90d
Cleared
May 25, 2017
revogene
K170558
·
OOI
Microbiology
·
90d
Filters
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5
Microbiology
5