510k
Database
Specialties
Anesthesiology
333
Cardiovascular
1070
Chemistry
271
Dental
816
Ear, Nose, Throat
148
Gastroenterology & Urology
630
General & Plastic Surgery
1323
General Hospital
763
Hematology
100
Immunology
72
Medical Genetics
1
Microbiology
366
Neurology
584
Obstetrics & Gynecology
244
Ophthalmic
155
Orthopedic
2055
Pathology
40
Physical Medicine
310
Radiology
1586
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
229
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
206
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
169
NHA
Abutment, Implant, Dental,...
160
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
135
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Coulter Electronics, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Coulter Electronics, Inc. - FDA 510(k) Cleared Devices
101 submissions
·
101 cleared
·
Since 1976
101
Total
101
Cleared
0
Denied
FDA 510(k) Regulatory Record - Coulter Electronics, Inc.
Toxicology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 14, 1987
DART THEOPHYLLINE REAGENT SYSTEM
K870736
·
KLS
Toxicology
·
48d
Cleared
Jan 13, 1987
DART PHENOBARBITAL ASSAY SYSTEM
K864612
·
LFN
Toxicology
·
50d
Cleared
Oct 03, 1978
MINI-KEM
K781576
·
JJQ
Toxicology
·
18d
Cleared
Aug 03, 1976
ASSAY, AMPHET. NDC#11711-0127-1 COULTER
K760196
·
DKZ
Toxicology
·
28d
Filters
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All
101
Hematology
51
Chemistry
43
Toxicology
4
Immunology
2
Pathology
1