SUTURE FIXATION DEVICE; MESH FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MALE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VARELISA PARIETAL CELL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

Second Opinion® BLE

FDA 510(k)

FDA Class 2 ·Radiology

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Herpes-1 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

LP(A) CALIBRATORS, AND LP(A) CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Herpes-2 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT IVANCOMYCIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NM-01/CPT neurometer (NM-01/CPT)

FDA 510(k)

FDA Class 2 ·Neurology

VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology