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1561
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227
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System, Imaging, Pulsed Doppler,...
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203
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System, Image Processing,...
196
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Electrosurgical, Cutting &...
185
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Orthopedic Stereotaxic Instrument
167
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Abutment, Implant, Dental,...
153
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Intervertebral Fusion Device...
136
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Thoracolumbosacral Pedicle Screw...
132
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OraSure Technologies, Inc.
Medical Device Manufacturer
·
US , Bethlehem , PA
OraSure Technologies, Inc. - FDA 510(k) Cleared Devices
30 submissions
·
29 cleared
·
Since 1996
30
Total
29
Cleared
1
Denied
FDA 510(k) Regulatory Record - OraSure Technologies, Inc.
Chemistry
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 26, 1996
STC AUTO-LYTE URINARY GLUCOSE ASSAY
K962435
·
CFR
Chemistry
·
185d
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30
Toxicology
22
General & Plastic Surgery
6
Microbiology
1
Chemistry
1