SINGLE-PATIENT USE DISPOSABLE SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVISION DATA MANAGEMENT SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS BONE CEMENT

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID

ASPARTATE AMINOTRANSFERASE (AST) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DATA-ZYME AST(GOT) PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DURAZYME GOT/AST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST S.C.E. (GOT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HICHEM AST REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNERMED AST/GOT REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE REAGENT FOR AST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry