SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

FDA 510(k)

FDA Class 2 ·Immunology

SPIFE URINE IFE

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Ebony PTA 0.035 Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Amethyst HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA .014 RX Pheripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tamarin Blue PTCA RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014 RX Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES WHOLE BLOOD ASSAY

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM