510k
Database
Specialties
Anesthesiology
529
Cardiovascular
1640
Chemistry
359
Dental
1312
Ear, Nose, Throat
239
Gastroenterology & Urology
950
General & Plastic Surgery
2164
General Hospital
2029
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
459
Neurology
950
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2798
Pathology
52
Physical Medicine
515
Radiology
2375
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
377
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
222
NHA
Abutment, Implant, Dental,...
205
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Gen-Probe, Inc.
Medical Device Manufacturer
·
US , San Diego , CA
Gen-Probe, Inc. - FDA 510(k) Cleared Devices
62 submissions
·
62 cleared
·
Since 1985
Official Website
62
Total
62
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gen-Probe, Inc.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 23, 1991
GEN-PROBE LUMINOMETER-LEADER 450
K905762
·
JJQ
Chemistry
·
27d
Cleared
Oct 04, 1990
GEN-PROBE PAL LUMINOMETER
K903911
·
JJQ
Chemistry
·
41d
Cleared
Sep 27, 1990
GEN-PROBE LUMINOMETER-LEADER 50
K903934
·
JJQ
Chemistry
·
31d
Cleared
Aug 21, 1987
GEN-PROBE (R) LUMINOMETER - LEADER (TM)
K872219
·
JJQ
Chemistry
·
70d
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62
Microbiology
58
Chemistry
4