510k
Database
Specialties
Anesthesiology
482
Cardiovascular
1460
Chemistry
338
Dental
1158
Ear, Nose, Throat
215
Gastroenterology & Urology
849
General & Plastic Surgery
1911
General Hospital
1453
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
432
Neurology
823
Obstetrics & Gynecology
364
Ophthalmic
239
Orthopedic
2512
Pathology
49
Physical Medicine
443
Radiology
2079
Toxicology
147
Categories
GEX
Powered Laser Surgical Instrument
311
LLZ
System, Image Processing,...
306
LZA
Polymer Patient Examination Glove
282
GEI
Electrosurgical, Cutting &...
263
QIH
Automated Radiological Image...
257
HRS
Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Bio-Tek Instruments, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Bio-Tek Instruments, Inc. - FDA 510(k) Cleared Devices
37 submissions
·
35 cleared
·
Since 1980
37
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bio-Tek Instruments, Inc.
Microbiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 22, 1985
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER
K853920
·
JTC
Microbiology
·
29d
Cleared
Mar 13, 1985
BIO-TEK AUTOMATED MICROPLATE WASHER EL402
K850249
·
JTC
Microbiology
·
50d
Cleared
Dec 22, 1980
THE BIO-TEK CHROMOSCAN
K803030
·
JJQ
Microbiology
·
24d
Filters
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All
37
Chemistry
15
Cardiovascular
7
Anesthesiology
5
Microbiology
3
General Hospital
2
Physical Medicine
2
General & Plastic Surgery
2
Radiology
1