510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
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963
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2875
Pathology
52
Physical Medicine
515
Radiology
2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Neumodx Molecular, Inc.
Medical Device Manufacturer
·
US , Ann Arbor , MI
Neumodx Molecular, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Neumodx Molecular, Inc.
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 22, 2023
NeuMoDx CT/NG Assay 2.0
K230267
·
QEP
Microbiology
·
325d
Cleared
Jun 26, 2018
NeuMoDx GBS Assay
K173725
·
NJR
Microbiology
·
203d
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2
Microbiology
2