510k
Database
Specialties
Anesthesiology
3169
Cardiovascular
9295
Chemistry
8200
Dental
5405
Ear, Nose, Throat
1787
Gastroenterology & Urology
4871
General & Plastic Surgery
7543
General Hospital
6204
Hematology
1855
Immunology
2394
Medical Genetics
15
Microbiology
4573
Neurology
2766
Obstetrics & Gynecology
1730
Ophthalmic
1314
Orthopedic
11886
Pathology
596
Physical Medicine
1459
Radiology
7999
Toxicology
2046
Categories
GEX
Powered Laser Surgical Instrument
1171
GEI
Electrosurgical, Cutting &...
1124
LLZ
System, Image Processing,...
1091
HRS
Plate, Fixation, Bone
903
LNH
System, Nuclear Magnetic...
813
IYN
System, Imaging, Pulsed Doppler,...
780
JWH
Prosthesis, Knee,...
765
GCJ
Laparoscope, General & Plastic...
682
ESD
Hearing Aid, Air-conduction,...
661
NKB
Thoracolumbosacral Pedicle Screw...
650
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
US
Hematronix, Inc.
Medical Device Manufacturer
·
US , Plano , TX
Hematronix, Inc. - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 1990
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hematronix, Inc.
Chemistry
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 20, 2001
MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
K012243
·
JJY
Chemistry
·
34d
Cleared
Aug 15, 1997
QUANTIFY(901)
K972710
·
JJW
Chemistry
·
25d
Cleared
Oct 26, 1990
METER TRAX
K904461
·
JPK
Chemistry
·
25d
Filters
Filter by Specialty
All
9
Hematology
6
Chemistry
3