MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II TEST SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV QUANT DX ASSAY

Oral Electronic Vision Aid

FDA classification

FDA Class 2 ·Oral Electronic Vision Aid

Software For Endoscopy Procedure Metrics

FDA classification

FDA Class 2 ·Software For Endoscopy Procedure Metrics

Catheter, Peritoneal, Long-Term Indwelling, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal, Long-Term Indwelling, Exempt

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Tester, Auditory Impedance, Exempt

FDA classification

FDA Class 2 ·Tester, Auditory Impedance, Exempt

Colposcope (And Colpomicroscope), Exempt

FDA classification

FDA Class 2 ·Colposcope (And Colpomicroscope), Exempt

System, Peritoneal, Automatic Delivery, Exempt

FDA classification

FDA Class 2 ·System, Peritoneal, Automatic Delivery, Exempt

Tympanometer, Exempt

FDA classification

FDA Class 2 ·Tympanometer, Exempt

Analyzer, Nitrogen Dioxide, Exempt

FDA classification

FDA Class 2 ·Analyzer, Nitrogen Dioxide, Exempt

Cream For X-Ray Attenuation

FDA classification

FDA Class 2 ·Cream For X-Ray Attenuation

Analyzer, Body Composition, Exempt

FDA classification

FDA Class 2 ·Analyzer, Body Composition, Exempt

Catheter, Peritoneal Dialysis, Single Use, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal Dialysis, Single Use, Exempt

Tenaculum, Uterine, Exempt

FDA classification

FDA Class 2 ·Tenaculum, Uterine, Exempt

Drape, Surgical, Exempt

FDA classification

FDA Class 2 ·Drape, Surgical, Exempt

Wire, Guide, Catheter, Exempt

FDA classification

FDA Class 2 ·Wire, Guide, Catheter, Exempt

Biliary Catheter For Irrigation And Contrast Injection, Exempt

FDA classification

FDA Class 2 ·Biliary Catheter For Irrigation And Contrast Injection, Exempt