MODEL 2188 CORONARY SINUS LEAD.

FDA 510(k)

FDA Class 3 ·Cardiovascular

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

HANK'S BALANCED SALTS (HBSS) NO. 200-2520

FDA 510(k)

FDA Class 1 ·Hematology

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

FDA 510(k)

FDA Class 2 ·Microbiology

TENONE(TM) OPIATES CATALOG: VKSO1,4

FDA 510(k)

FDA Class 1 ·Immunology

GAMBRO BICARBONATE MONITOR BCM 10-2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINIMUM ESSENTIAL MEDIUM EAGLE NO. 210-3510

FDA 510(k)

FDA Class 1 ·Hematology

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

MCCOY'S 5A MEDIUM NO. 210-3530

FDA 510(k)

FDA Class 1 ·Hematology

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

NUTRIENT MIXTURE F-12 (HAM), NO. 210-3551

FDA 510(k)

FDA Class 1 ·Hematology

HANK'S BALANCED SALTS (HBSS) NO. 200-2521

FDA 510(k)

FDA Class 1 ·Hematology

MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531)

FDA 510(k)

FDA Class 1 ·Hematology