510k
Database
Specialties
Anesthesiology
332
Cardiovascular
1058
Chemistry
268
Dental
800
Ear, Nose, Throat
148
Gastroenterology & Urology
621
General & Plastic Surgery
1318
General Hospital
748
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
365
Neurology
573
Obstetrics & Gynecology
243
Ophthalmic
155
Orthopedic
2044
Pathology
39
Physical Medicine
309
Radiology
1580
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
209
IYN
System, Imaging, Pulsed Doppler,...
208
QIH
Automated Radiological Image...
205
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
155
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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Abbott Diagnostics
Medical Device Manufacturer
·
US , Mountain View , CA
Abbott Diagnostics - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1981
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Diagnostics
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 08, 1987
MODEL 690 SPECTROPHOTOMETER
K873408
·
JJQ
Chemistry
·
14d
Cleared
Sep 14, 1984
DYNA-LYTE 2000
K842786
·
CEM
Chemistry
·
115d
Cleared
Oct 08, 1982
MODEL 340 SPECTROPHOTOMETER
K822720
·
JJQ
Chemistry
·
31d
Cleared
Feb 10, 1981
MODEL AM 721 ELECTROLYTE ANALYZER
K810135
·
JGS
Chemistry
·
20d
Filters
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28
Hematology
20
Chemistry
4
Toxicology
2
Immunology
1
Microbiology
1