510k
Database
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332
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1061
Chemistry
269
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805
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148
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622
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1321
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752
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98
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72
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1
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365
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574
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244
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155
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2050
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40
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309
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1581
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132
Categories
GEX
Powered Laser Surgical Instrument
228
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Plate, Fixation, Bone
210
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System, Imaging, Pulsed Doppler,...
208
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Automated Radiological Image...
205
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
156
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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Lkb Instruments, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Lkb Instruments, Inc. - FDA 510(k) Cleared Devices
52 submissions
·
52 cleared
·
Since 1976
52
Total
52
Cleared
0
Denied
FDA 510(k) Regulatory Record - Lkb Instruments, Inc.
Toxicology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 11, 1986
DELFIA DIGOXIN
K861195
·
KXT
Toxicology
·
102d
Cleared
Aug 02, 1985
1208 BETACORD AND 1208 BETCORD M
K852434
·
JJJ
Toxicology
·
53d
Cleared
May 20, 1985
NOVASPEC VISIBLE SPECTROPHOTOMETER
K851572
·
JJQ
Toxicology
·
33d
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52
Chemistry
31
Anesthesiology
5
Hematology
4
Pathology
3
Toxicology
3
Microbiology
2
Radiology
1
Immunology
1
Cardiovascular
1
General Hospital
1