LABELING CHANGE COAT-A-COUNT SERUM MORPHINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RING-LOK MODULAR BIPOLAR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

QUANTIMETRIX BILIRUBIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAMBRO BICART SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENGSTROM ELIZA + CO2 ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

VisAble.IO

FDA 510(k)

FDA Class 2 ·Radiology

SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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