MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EzDent-i / E2 / Prora View

FDA 510(k)

FDA Class 2 ·Radiology

Ez3D-i / E3

FDA 510(k)

FDA Class 2 ·Radiology

ARIX Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Safey Pocket Spirometer

FDA 510(k)

FDA Class 2 ·Anesthesiology

Safey Peak Flow Meter

FDA 510(k)

FDA Class 2 ·Anesthesiology

FINOMETER MODEL-2 WITH ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

DW-1C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Ez3D-i / E3

FDA 510(k)

FDA Class 2 ·Radiology

Uni-port

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Optixon 1-Day

FDA 510(k)

FDA Class 2 ·Ophthalmic

Adhesive Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

EzDent-i / E2 / Prora View

FDA 510(k)

FDA Class 2 ·Radiology

ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anit-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM ANTI-HCV