OSTEOMARK NTX POC

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

POC ENT ENDOSCOPE - SINUSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

POC ARTHROSCOPE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

POC-AS10 AUTO SAMPLER

FDA 510(k)

FDA Class 1 ·Microbiology

AFINION ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

AFINION HBALC

FDA 510(k)

FDA Class 2 ·Hematology

AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AFINION ACR AND ACR CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIAZYME HSCRP POC TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIAZYME HOMOCYSTEINE POC TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIAZYME CYSTATIN C POC TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX Check-Points CPO

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

FDA 510(k)

FDA Class 2 ·Radiology

Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

FDA 510(k)

FDA Class 2 ·Radiology

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

FDA 510(k)

FDA Class 2 ·Radiology

SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry