TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PC/QCT QUANTITATIVE SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

GAMBRO BICARBONATE MONITOR BCM 10-2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED DPX BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

ALDAHOL III HIGH-LEVEL DISINFECTANT

FDA 510(k)

FDA Class 2 ·General Hospital

LABELING CHANGES COAT-A-COUNT METHADONE IN URINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CUFFED TRACHEAL TUBE (MULTIPLE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

GV 11 (TM), MODEL 9700

FDA 510(k)

FDA Class 2 ·Physical Medicine

28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)

FDA 510(k)

FDA Class 2 ·Immunology

ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE

FDA 510(k)

FDA Class 2 ·General Hospital

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