510k
Database
Specialties
Anesthesiology
132
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566
Chemistry
162
Dental
310
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
370
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
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163
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61
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49
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1288
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Immunexpress, Inc.
Medical Device Manufacturer
·
US , Seattle , WA
Immunexpress, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Immunexpress, Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 15, 2023
SeptiCyte RAPID
K232095
·
PRE
Microbiology
·
155d
Cleared
Nov 29, 2021
SeptiCyte RAPID
K203748
·
PRE
Microbiology
·
341d
Cleared
Feb 17, 2017
SeptiCyte LAB
K163260
·
PRE
Microbiology
·
88d
Filters
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3
Microbiology
3