510k
Database
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Anesthesiology
330
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1055
Chemistry
268
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793
Ear, Nose, Throat
148
Gastroenterology & Urology
619
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1307
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746
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97
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72
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1
Microbiology
364
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565
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240
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154
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2032
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38
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309
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1570
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130
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GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
208
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System, Imaging, Pulsed Doppler,...
207
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Automated Radiological Image...
204
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System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
133
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Alpha-Tec Systems, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Alpha-Tec Systems, Inc. - FDA 510(k) Cleared Devices
18 submissions
·
18 cleared
·
Since 1983
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alpha-Tec Systems, Inc.
Hematology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 07, 1983
ATS GRAM STAIN CONTROL SLIDE
K823704
·
LJG
Hematology
·
29d
Cleared
Jan 07, 1983
ATS PARASITOLOGY STAIN CONTROL SLIDE
K823705
·
LJG
Hematology
·
29d
Cleared
Jan 07, 1983
ATS AFB STAIN CONTROL SLIDE
K823706
·
LJG
Hematology
·
29d
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18
Pathology
12
Hematology
3
Microbiology
3