Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott RealTime HCV Genotype II

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE 11

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

VI-FLOW PUMP WITH VI-SET

FDA 510(k)

FDA Class 2 ·General Hospital

PULSE CRP TEST

FDA 510(k)

FDA Class 2 ·Immunology

PULSE RF TEST

FDA 510(k)

FDA Class 2 ·Immunology

TEX-AID BLUE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PULSE IM RED CELL TEST

FDA 510(k)

FDA Class 2 ·Immunology

MAXCEM 2

FDA 510(k)

FDA Class 2 ·Dental

SOOTHE-N-SEAL CANKER SORE RELIEF

FDA 510(k)

FDA Class 2 ·Dental

VAX-T PELVIC TRACTION BELT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Carex Hybrid Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LARGE/EXTRA LAGRE CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software

BLACK COLOURED CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NATURAL RUBBER LATEX MALE CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ORANGE COLORED CONDOMS ORANGE SCENT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology