510k
Database
Specialties
Anesthesiology
553
Cardiovascular
1736
Chemistry
387
Dental
1407
Ear, Nose, Throat
258
Gastroenterology & Urology
997
General & Plastic Surgery
2244
General Hospital
2105
Hematology
127
Immunology
105
Medical Genetics
8
Microbiology
477
Neurology
988
Obstetrics & Gynecology
452
Ophthalmic
286
Orthopedic
3087
Pathology
52
Physical Medicine
517
Radiology
2517
Toxicology
156
Categories
LZA
Polymer Patient Examination Glove
423
LLZ
System, Image Processing,...
402
GEX
Powered Laser Surgical Instrument
366
FXX
Mask, Surgical
361
GEI
Electrosurgical, Cutting &...
313
IYN
System, Imaging, Pulsed Doppler,...
306
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
238
MAX
Intervertebral Fusion Device...
235
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Immucor, Inc.
Medical Device Manufacturer
·
US , Norcross , GA
Immucor, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1991
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Immucor, Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 22, 2021
Capture-CMV
K203612
·
LJO
Microbiology
·
102d
Cleared
Feb 04, 2019
Capture-CMV
K183571
·
LJO
Microbiology
·
45d
Cleared
Mar 20, 1991
CYTOMEGALOVIRUS ANTIBODY SCREEN
K910003
·
LJO
Microbiology
·
77d
Filters
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3
Microbiology
3