Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

Lingo Glucose System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Confirm Rx Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Confirm Rx Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

MitraClip G4 Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

WorkMate Claris System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CentriMag Pre-connected Pack

FDA 510(k)

FDA Class 2 ·Cardiovascular

EnSite X EP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA TEST KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM HAVAB-M 2.0

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP (LIST 7A48)

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA LABELING CHANGE

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM CEA (LIST 7A47)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP