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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBc IgM 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-HBC IGM REAGENT PACK & CALIBRATORS

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE, IMMULITE 1000 ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBCIGM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur® and Atellica IM Hepatitis B Core IgM (AHBcM) Assay

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700/600,650,800/900 FAMILY, SIGMA FAMILY, MEDTRONIC 350 SERIES, ENPILSE 2 FAMILY ENRHYTHM, ADAPTA/VERSA/SESIA FAM

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