510k
Database
Specialties
Anesthesiology
333
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1068
Chemistry
270
Dental
809
Ear, Nose, Throat
148
Gastroenterology & Urology
628
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1322
General Hospital
760
Hematology
99
Immunology
72
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1
Microbiology
366
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582
Obstetrics & Gynecology
244
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155
Orthopedic
2055
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40
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310
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1585
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
229
HRS
Plate, Fixation, Bone
211
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System, Imaging, Pulsed Doppler,...
208
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Automated Radiological Image...
206
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
169
NHA
Abutment, Implant, Dental,...
158
MAX
Intervertebral Fusion Device...
138
NKB
Thoracolumbosacral Pedicle Screw...
135
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Reagent Laboratory, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Reagent Laboratory, Inc. - FDA 510(k) Cleared Devices
19 submissions
·
18 cleared
·
Since 1984
19
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Reagent Laboratory, Inc.
Hematology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 03, 1986
HEMOLYSE
K863503
·
GGK
Hematology
·
24d
Cleared
May 31, 1984
CYANOMETHEMOGLOBIN REAGENT
K841799
·
GIF
Hematology
·
43d
Cleared
May 31, 1984
LYSING & HEMOGLOBIN REAGENT
K841800
·
GGK
Hematology
·
43d
Cleared
May 21, 1984
SODIUM CHLORIDE SOLUTION BLOOD CELL
K841183
·
FNW
Hematology
·
62d
Filters
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19
Chemistry
9
Pathology
4
Hematology
4
Toxicology
1
Microbiology
1