MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST

FDA 510(k)

FDA Class 2 ·Immunology

AURA TEK FDP

FDA 510(k)

FDA Class 2 ·Immunology

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

FDA 510(k)

FDA Class 2 ·Immunology

NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT

FDA 510(k)

FDA Class 2 ·Immunology

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

BARD AND BTA TEST

FDA 510(k)

FDA Class 2 ·Immunology

BARD BTA TRAK TEST

FDA 510(k)

FDA Class 2 ·Immunology

UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

BTA STAT TEST PRESCRIPTION HOME USE

FDA 510(k)

FDA Class 2 ·Immunology

System, Test, Tumor Marker, Monitoring, Bladder

FDA classification

FDA Class 2 ·System, Test, Tumor Marker, Monitoring, Bladder

DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

GLYCOMAT HAEMOGLOBIN ANALYSER

FDA 510(k)

FDA Class 2 ·Hematology

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

FDA 510(k)

FDA Class 2 ·Hematology

745 GLYCOMAT

FDA 510(k)

FDA Class 2 ·Hematology

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.

DEPUY CMW 1 GENTAMICIN BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

ANTI-KERATIN-HMW PRIMARY ANTI-BODY

FDA 510(k)

FDA Class 2 ·Immunology

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW 1 RADIOPAQUE, CMW2 AND CMW3 BONE CEMENTS

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEPUY CMW 1, 2 AND 3 BONE CEMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic