Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ARMSOF SOFT CONTACT LENSE

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

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC IMMULITE SUBSTRATE REAGENT

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® 2000 Anti-HBc

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

FDA Pre-Market Approval

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

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Plasmaflo OP-05W(A)

FDA Pre-Market Approval

IMMULITE® 2000 HBsAg, IMMULITE® 2000 HBsAg Confirmatory

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ARMSOF SOFT CONTACT LENSE

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO AP-05H ASAHI PLASMA SEPARATOR

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

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC IMMULITE ASSAY

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 HBs Ag Confirmatory

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 Anti-HBs

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO OP-05W(A)

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000, IMMULITE 2000 HBSAG/HBSAG CONFIMATORY

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC Scoring PTCA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 Anti-HBc IgM

FDA Pre-Market Approval

IMMULITE® 2000 Anti-HBs

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Scoreflex NC

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 ASSAYS