510k
Database
Specialties
Anesthesiology
1092
Cardiovascular
4501
Chemistry
3346
Dental
2794
Ear, Nose, Throat
469
Gastroenterology & Urology
2444
General & Plastic Surgery
4116
General Hospital
3840
Hematology
808
Immunology
796
Medical Genetics
15
Microbiology
1737
Neurology
1772
Obstetrics & Gynecology
884
Ophthalmic
497
Orthopedic
7747
Pathology
167
Physical Medicine
963
Radiology
4789
Toxicology
1242
Categories
LLZ
System, Image Processing,...
730
HRS
Plate, Fixation, Bone
696
GEI
Electrosurgical, Cutting &...
568
IYN
System, Imaging, Pulsed Doppler,...
535
GEX
Powered Laser Surgical Instrument
521
JWH
Prosthesis, Knee,...
496
LZA
Polymer Patient Examination Glove
489
LNH
System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
406
FXX
Mask, Surgical
400
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
Home
Manufacturers
US
Tecan U.S., Inc.
Medical Device Manufacturer
·
US , Research Triangle Park , NC
Tecan U.S., Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1994
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tecan U.S., Inc.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 18, 1997
GENESIS RMP
K963268
·
JRA
Chemistry
·
210d
Cleared
Nov 21, 1995
GENESIS
K953345
·
JQW
Chemistry
·
132d
Cleared
Oct 25, 1994
4 CHANNEL DISPENSER
K944556
·
JQW
Chemistry
·
39d
Cleared
Sep 02, 1994
4 CHANNEL DISPENSER
K942655
·
JQW
Chemistry
·
88d
Filters
Filter by Specialty
All
4
Chemistry
4