510k
Database
Specialties
Anesthesiology
3170
Cardiovascular
9307
Chemistry
8200
Dental
5408
Ear, Nose, Throat
1788
Gastroenterology & Urology
4875
General & Plastic Surgery
7580
General Hospital
6205
Hematology
1855
Immunology
2394
Medical Genetics
15
Microbiology
4574
Neurology
2767
Obstetrics & Gynecology
1732
Ophthalmic
1318
Orthopedic
11889
Pathology
596
Physical Medicine
1459
Radiology
7999
Toxicology
2046
Categories
GEX
Powered Laser Surgical Instrument
1171
GEI
Electrosurgical, Cutting &...
1130
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...
692
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
Primeradx
Medical Device Manufacturer
·
US , Mansfield , MA
Primeradx - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2013
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Primeradx
Microbiology
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 29, 2013
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
K132726
·
OZN
Microbiology
·
91d
Filters
Filter by Specialty
All
1
Microbiology
1