510k
Database
Specialties
Anesthesiology
331
Cardiovascular
1056
Chemistry
268
Dental
794
Ear, Nose, Throat
148
Gastroenterology & Urology
619
General & Plastic Surgery
1308
General Hospital
747
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
364
Neurology
567
Obstetrics & Gynecology
242
Ophthalmic
154
Orthopedic
2038
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38
Physical Medicine
309
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1575
Toxicology
131
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
208
IYN
System, Imaging, Pulsed Doppler,...
207
QIH
Automated Radiological Image...
205
LLZ
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...
135
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Inbios Intl., Inc.
Medical Device Manufacturer
·
US , Seattle , WA
Inbios Intl., Inc. - FDA 510(k) Cleared Devices
6 submissions
·
5 cleared
·
Since 1999
6
Total
5
Cleared
1
Denied
FDA 510(k) Regulatory Record - Inbios Intl., Inc.
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 26, 2000
GENERIC BLOOD GLUCOSE TEST STRIP
K001092
·
CGA
Chemistry
·
113d
Cleared
Oct 18, 1999
INSURE PRO TEST
K992695
·
JHI
Chemistry
·
68d
Cleared
May 28, 1999
INSURE PREGNANCY TEST
K991515
·
DHA
Chemistry
·
28d
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6
Chemistry
3
Microbiology
3