IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOWELL RNP/SM ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

HEMOSPAL KITS A1, A2D, AO, & A1D

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

FDA 510(k)

FDA Class 2 ·Hematology

ACSYS SHEARER ACETABULAR CUP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIEMENS SIRECUST 732, PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HALL VEIN STRIPPER

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE DDI SERODOT RUBELLA IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL T11 FLUIDOTHERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Z-800 INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

THE IMAGE/R

FDA 510(k)

FDA Class 2 ·Radiology

PRECEPT CEFTIZOXIME

FDA 510(k)

FDA Class 2 ·Microbiology

Lung-CAD

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED DDI SEROCARD HERPES IGG TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MILENIA(TM) OPIATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ULTRAPAC II SX PLUS (TM)

FDA 510(k)

FDA Class 2 ·Neurology