510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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Biokit, S.A.
Medical Device Manufacturer
·
ES , Barcelona
Biokit, S.A. - FDA 510(k) Cleared Devices
23 submissions
·
23 cleared
·
Since 2005
23
Total
23
Cleared
0
Denied
FDA 510(k) cleared devices by Biokit, S.A.
Immunology
✕
5
devices
1-5 of 5
Filters
Cleared
Feb 21, 2023
Quantia IgE
K214068
·
DGC
Immunology
·
421d
Cleared
Dec 19, 2007
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
K072078
·
JZG
Immunology
·
142d
Cleared
Aug 16, 2005
QUANTIA IGE
K050493
·
DGC
Immunology
·
169d
Cleared
Aug 16, 2005
QUANTIA BETA-2 MICROGLOBULIN
K050613
·
JZG
Immunology
·
159d
Cleared
May 13, 2005
QUANTIA A1-AT
K050596
·
DEM
Immunology
·
66d
Filters
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All
23
Chemistry
8
Microbiology
6
Immunology
5
Toxicology
4