510k
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Anesthesiology
338
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1076
Chemistry
273
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827
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149
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639
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1339
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778
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100
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72
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1
Microbiology
369
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591
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249
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159
Orthopedic
2068
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40
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314
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1601
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
231
HRS
Plate, Fixation, Bone
211
IYN
System, Imaging, Pulsed Doppler,...
209
QIH
Automated Radiological Image...
208
LLZ
System, Image Processing,...
200
GEI
Electrosurgical, Cutting &...
186
OLO
Orthopedic Stereotaxic Instrument
170
NHA
Abutment, Implant, Dental,...
162
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
138
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Marion Laboratories, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Marion Laboratories, Inc. - FDA 510(k) Cleared Devices
38 submissions
·
34 cleared
·
Since 1978
38
Total
34
Cleared
0
Denied
FDA 510(k) Regulatory Record - Marion Laboratories, Inc.
Hematology
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 10, 1980
HEMOTEMP TM
K802319
·
KSE
Hematology
·
17d
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38
Microbiology
18
General & Plastic Surgery
6
Toxicology
5
Chemistry
3
Pathology
2
Physical Medicine
1
Immunology
1
Anesthesiology
1
Hematology
1