LP(A)-LATEX SEIKEN ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

FDA 510(k)

FDA Class 2 ·Immunology

APOB

FDA 510(k)

FDA Class 2 ·Immunology

LIPPOPROTEIN ELECTROPHORESIS REAGENT SET

FDA 510(k)

FDA Class 2 ·Immunology

LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

FDA 510(k)

FDA Class 2 ·Immunology

RAICHEM(TM) SPIA(TM) APO B REAGENTS

FDA 510(k)

FDA Class 2 ·Immunology

QM300 CALIBRATOR F PACK

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

FDA 510(k)

FDA Class 2 ·Immunology

WAKO AUTOKIT LP(A)/EXPRESS 550

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

WAKO AUTOKIT LP(A)/DADE DEMENSION

FDA 510(k)

FDA Class 2 ·Immunology

INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B

FDA 510(k)

FDA Class 2 ·Immunology

UC IMU B

FDA 510(k)

FDA Class 2 ·Immunology

QUANTIA LA(A)

FDA 510(k)

FDA Class 2 ·Immunology

RSI FEMORAL GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT

FDA 510(k)

FDA Class 2 ·General Hospital

AMICAS VISION SERIES PACS, MODEL 4.3

FDA 510(k)

FDA Class 2 ·Radiology

AMICAS PACS, VERSION 6.0

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

FDA 510(k)

FDA Class 2 ·Microbiology