CSF/URINE TOTAL PROTEIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

FDA 510(k)

FDA Class 2 ·Neurology

RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST

FDA 510(k)

FDA Class 2 ·Immunology

IF-727 INTERFERENTIAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC

FDA 510(k)

FDA Class 2 ·Hematology

SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN

FDA 510(k)

FDA Class 2 ·Hematology

DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)

FDA 510(k)

FDA Class 2 ·Hematology

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NAV PAK Needle, NIM NAV PAK Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HawkOne Directional Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vivid E80, Vivid E90, Vivid E95

FDA 510(k)

FDA Class 2 ·Radiology

Venue Fit

FDA 510(k)

FDA Class 2 ·Radiology

Venue

FDA 510(k)

FDA Class 2 ·Radiology

3-Ply Disposable Medical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II

FDA 510(k)

FDA Class 2 ·Hematology

MI-328, MI-316, MI-388 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OFNat Lubricant (L15)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Microthin Natural Rubber Latex Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology