510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
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2194
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2047
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126
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99
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8
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469
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965
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433
Ophthalmic
275
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2923
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52
Physical Medicine
515
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2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Gold Standard Diagnostics
Medical Device Manufacturer
·
US , Davis , CA
Gold Standard Diagnostics - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 2012
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gold Standard Diagnostics
Immunology
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 28, 2014
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
K131330
·
LJM
Immunology
·
265d
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14
Microbiology
13
Immunology
1