510k
Database
Specialties
Anesthesiology
7175
Cardiovascular
15976
Chemistry
11746
Dental
10984
Ear, Nose, Throat
3094
Gastroenterology & Urology
8523
General & Plastic Surgery
15674
General Hospital
13902
Hematology
2803
Immunology
3321
Medical Genetics
20
Microbiology
6176
Neurology
5407
Obstetrics & Gynecology
3743
Ophthalmic
3857
Orthopedic
17421
Pathology
911
Physical Medicine
3867
Radiology
14000
Toxicology
2797
Categories
Powered Laser Surgical Instrument
GEX
2682
System, Image Processing, Radiological
LLZ
2233
Electrosurgical, Cutting &...
GEI
2143
Implant, Endosseous, Root-form
DZE
1425
Laparoscope, General & Plastic Surgery
GCJ
1355
Plate, Fixation, Bone
HRS
1313
Polymer Patient Examination Glove
LZA
1173
System, Imaging, Pulsed Doppler,...
IYN
1166
System, Nuclear Magnetic Resonance...
LNH
1068
System, Measurement,...
DXN
1046
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Bicarbolyte Corp.
Share
Medical Device Manufacturer
·
US , Charlottesville , VA
Bicarbolyte Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1985
View 2 510(k) Devices ↓
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bicarbolyte Corp.
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 27, 1987
POWDERED BICARBONATE CONCENTRATE
K865078
·
KPO
Gastroenterology & Urology
·
88d
Cleared
Jan 09, 1985
HEMODIALYSATE SOLUTIONS
K843866
·
KPO
Gastroenterology & Urology
·
99d
Filters
Filter by Specialty
All
2
Gastroenterology & Urology
2