510k
Database
Specialties
Anesthesiology
547
Cardiovascular
1714
Chemistry
380
Dental
1356
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2217
General Hospital
2087
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
441
Ophthalmic
283
Orthopedic
3042
Pathology
52
Physical Medicine
515
Radiology
2492
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
295
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
232
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Streck, Inc.
Medical Device Manufacturer
·
US , La Vista , NE
Streck, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
2 cleared
·
Since 2020
3
Total
2
Cleared
1
Denied
FDA 510(k) Regulatory Record - Streck, Inc.
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 26, 2024
Cell-Free DNA BCT
K231776
·
QMA
Chemistry
·
406d
Not Cleared
Aug 07, 2020
Cell-Free DNA BCT
DEN200001
·
QMA
Chemistry
·
210d
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3
Chemistry
2
Microbiology
1