510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
275
Orthopedic
2923
Pathology
52
Physical Medicine
515
Radiology
2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Cue Health, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Cue Health, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 2023
2
Total
1
Cleared
1
Denied
FDA 510(k) Regulatory Record - Cue Health, Inc.
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 28, 2023
Cue COVID-19 Molecular Test
K232643
·
QWB
Microbiology
·
90d
Not Cleared
Jun 06, 2023
Cue COVID-19 Molecular Test
DEN220028
·
QWB
Microbiology
·
400d
Filters
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2
Microbiology
2