510k
Database
Specialties
Anesthesiology
511
Cardiovascular
1590
Chemistry
356
Dental
1282
Ear, Nose, Throat
234
Gastroenterology & Urology
922
General & Plastic Surgery
2112
General Hospital
1890
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
931
Obstetrics & Gynecology
422
Ophthalmic
267
Orthopedic
2683
Pathology
51
Physical Medicine
507
Radiology
2297
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
392
LLZ
System, Image Processing,...
358
GEX
Powered Laser Surgical Instrument
348
GEI
Electrosurgical, Cutting &...
292
FXX
Mask, Surgical
289
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Vivachek Biotech (Hangzhou) Co., Ltd.
Medical Device Manufacturer
·
CN , Hangzhou
Vivachek Biotech (Hangzhou) Co., Ltd. - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 2020
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 16, 2024
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood...
K222126
·
NBW
Chemistry
·
760d
Cleared
Dec 22, 2023
VivaChek Link Plus Blood Glucose Monitoring System
K233058
·
NBW
Chemistry
·
88d
Cleared
Jun 05, 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957
·
JIN
Chemistry
·
228d
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9
Toxicology
6
Chemistry
3