510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2176
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
959
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2838
Pathology
52
Physical Medicine
515
Radiology
2413
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
213
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Trinity Laboratories, Inc.
Medical Device Manufacturer
·
US , Raleigh , NC
Trinity Laboratories, Inc. - FDA 510(k) Cleared Devices
44 submissions
·
28 cleared
·
Since 1990
44
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Trinity Laboratories, Inc.
Immunology
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 01, 1997
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE...
K972160
·
DCK
Immunology
·
53d
Cleared
Dec 07, 1992
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
K915320
·
DHR
Immunology
·
381d
Cleared
Jun 28, 1990
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K902541
·
KTN
Immunology
·
22d
Filters
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All
44
General Hospital
13
General & Plastic Surgery
13
Anesthesiology
7
Immunology
3
Microbiology
3
Gastroenterology & Urology
2
Dental
1
Obstetrics & Gynecology
1
Cardiovascular
1