DART PHENOBARBITAL ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HC PLUS

FDA 510(k)

FDA Class 2 ·Hematology

COULTER CLONE T11 MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Hematology

UNIMODE(TM) POWER MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

17HQ901G-B

FDA 510(k)

FDA Class 2 ·Radiology

SERIES 1500 DEFIBRILLATOR, MODIFICATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

APELLO, PERSONAL HEALTH SUPPORT SYS.

FDA 510(k)

FDA Class 2 ·Physical Medicine

MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

COULTER DIRECT BILLRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DAHLBERG MODEL AM

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

TYPE FP30 DIGITAL HEARING AID ANALYZER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COULTER URIC ACID REAGENT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DART UREA NITROGEN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRAMSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PDS 9000 PATIENT DATA MGMT. SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFE-MASK INFANT RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACTIVE MODEL AHS HALF SHELL ITE HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

COULTER VISCOMETER II

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TELSTAR PREWIRE SERIES

FDA 510(k)

FDA Class 2 ·General Hospital

COULTER CK-MB ISOENZYME REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry