CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOX AMMONIA CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA TESTPOINT CSF CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

R & D 4K RETIC

FDA 510(k)

FDA Class 2 ·Hematology

CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

QBC CENTRIFUGAL HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

ADVIA CENTAUR HOMOCYSTEINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA RETIC PLUS

FDA 510(k)

FDA Class 2 ·Hematology

CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.

FDA 510(k)

FDA Class 2 ·Neurology

CBC-SF

FDA 510(k)

FDA Class 2 ·Hematology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA 60 HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN

FDA 510(k)

FDA Class 2 ·Dental

BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD

FDA 510(k)

FDA Class 2 ·Radiology

ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE

FDA 510(k)

FDA Class 2 ·Immunology

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX PERFUSION CORON. DILATION CATHETER ADD 2.0