510k
Database
Specialties
Anesthesiology
330
Cardiovascular
1055
Chemistry
268
Dental
793
Ear, Nose, Throat
148
Gastroenterology & Urology
619
General & Plastic Surgery
1307
General Hospital
746
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
364
Neurology
566
Obstetrics & Gynecology
240
Ophthalmic
154
Orthopedic
2032
Pathology
38
Physical Medicine
309
Radiology
1570
Toxicology
130
Categories
GEX
Powered Laser Surgical Instrument
227
HRS
Plate, Fixation, Bone
208
IYN
System, Imaging, Pulsed Doppler,...
207
QIH
Automated Radiological Image...
204
LLZ
System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
133
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Sigma Chemical Co.
Medical Device Manufacturer
·
US , Mchenry , IL
Sigma Chemical Co. - FDA 510(k) Cleared Devices
231 submissions
·
231 cleared
·
Since 1976
Official Website
231
Total
231
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sigma Chemical Co.
Toxicology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 17, 1987
THEOPHYLLINE FPIA CONTROLS
K871589
·
LAW
Toxicology
·
54d
Cleared
Jul 27, 1981
SIGMA PROCEDURE #890
K811784
·
GJS
Toxicology
·
34d
Cleared
May 15, 1981
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE
K811011
·
GIA
Toxicology
·
30d
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All
231
Chemistry
104
Pathology
73
Hematology
40
Microbiology
8
Immunology
3
Toxicology
3