510k
Database
Specialties
Anesthesiology
473
Cardiovascular
1428
Chemistry
335
Dental
1126
Ear, Nose, Throat
209
Gastroenterology & Urology
837
General & Plastic Surgery
1885
General Hospital
1420
Hematology
125
Immunology
87
Medical Genetics
8
Microbiology
424
Neurology
810
Obstetrics & Gynecology
360
Ophthalmic
235
Orthopedic
2470
Pathology
49
Physical Medicine
434
Radiology
2055
Toxicology
145
Categories
GEX
Powered Laser Surgical Instrument
305
LLZ
System, Image Processing,...
304
LZA
Polymer Patient Examination Glove
272
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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Roche Diagnostics GmbH
Medical Device Manufacturer
·
DE , Mannheim
Roche Diagnostics GmbH - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1998
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roche Diagnostics GmbH
Immunology
✕
1
devices
1-1 of 1
Filters
Cleared
May 01, 1998
ELECSYS AFP
K981282
·
LOJ
Immunology
·
23d
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5
Chemistry
3
Immunology
1
General Hospital
1