System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA KIT

Cyclosporine Radioimmunoassay

FDA Pre-Market Approval

FDA Class 2 ·SANDIMMUNE(R) RADIOIMMUNOASSAY KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

Aneroid Type Blood Pressure Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUEST VEIN GRAFT PERFUSION SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED GATEWAY PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXYGENATOR HOLDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LARGE LUMEN Y ADAPTER W/ROTATING DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TUBING CONNECTORS EC-2XXX SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

USCI TANDEM ADAPTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CUSTOM TUBING PACKS

FDA 510(k)

FDA Class 2 ·Cardiovascular

VYGON STOPCOCKS & RAMPS(MANIFOLDS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MANIFOLD CLAMPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADAPTERS WITH X-COATING

FDA 510(k)

FDA Class 2 ·Cardiovascular

MALE-MALE LUER LOCK CONNECTOR W/ROTA

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTATING ADAPTERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMOSTASIS VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARTERIAL FILTER PURGE LINE W/CHECK VALV

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADAPTERS-Y-TYPE

FDA 510(k)

FDA Class 2 ·Cardiovascular