Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC ANTI-HBS REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS & CALIBRATORS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART CONTROL NITINOL STENT SYSTEM

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx

K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE PEDIATRIC ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE, MODEL KDP-60A

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE PEDIATRIC ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602

FDA 510(k)

FDA Class 3 ·Cardiovascular

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR