FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

FDA 510(k)

FDA Class 2 ·Immunology

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

FDA 510(k)

FDA Class 2 ·Immunology

MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS

FDA 510(k)

FDA Class 2 ·Hematology

HYDRASHIFT 2/4 daratumumab

FDA 510(k)

FDA Class 2 ·Immunology

GELSCAN, MODEL 1206

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HYDRASHIFT 2/4 daratumumab, daratumumab Control

FDA 510(k)

FDA Class 2 ·Immunology

MINICAP IMMUNOTYPING, MODEL: 2300

FDA 510(k)

FDA Class 2 ·Immunology

CAPILLARYS URINE (PN 2012)

FDA 510(k)

FDA Class 2 ·Immunology

CAPILLARY'S IMMUNOTYPING (PN 2100)

FDA 510(k)

FDA Class 2 ·Immunology

Visaris Avanse

FDA 510(k)

FDA Class 2 ·Radiology

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

FDA 510(k)

FDA Class 2 ·Radiology

EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)

FDA 510(k)

FDA Class 2 ·Orthopedic

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery