FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

FDA 510(k)

FDA Class 2 ·General Hospital

Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACS:CENTAUR PSA2 IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA, MODEL 2010

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 PSA

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 3RD GENERATION PSA

FDA 510(k)

FDA Class 2 ·Immunology

QUALISYS PSA IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION PSA FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA (ON ELECSYS 1010)

FDA 510(k)

FDA Class 2 ·Immunology

FREND PSA PLUS (reagent cartridge)

FDA 510(k)

FDA Class 2 ·Immunology

ENZYMUN-TEST PSA

FDA 510(k)

FDA Class 2 ·Immunology

VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

FDA 510(k)

FDA Class 2 ·Immunology

FREND PSA PLUS (REAGENT CARTRIDGE)

FDA 510(k)

FDA Class 2 ·Immunology

ELECSYS PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology