510k
Database
Specialties
Anesthesiology
522
Cardiovascular
1608
Chemistry
356
Dental
1300
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1973
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
940
Obstetrics & Gynecology
426
Ophthalmic
271
Orthopedic
2696
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
402
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
346
GEI
Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Biomerica, Inc.
Medical Device Manufacturer
·
US , Newport Beach , CA
Biomerica, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1991
Official Website
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomerica, Inc.
Immunology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 27, 1995
ANTI-TPO
K954256
·
JNL
Immunology
·
83d
Cleared
Jul 18, 1994
THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
K936010
·
DDC
Immunology
·
214d
Filters
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10
Chemistry
5
Microbiology
3
Immunology
2