CARDIAC TROPONIN-I (TROP) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Fixated Asfora BULLET CAGE® (FABC)

FDA 510(k)

FDA Class 2 ·Orthopedic

DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MMB METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST

FDA 510(k)

FDA Class 2 ·Immunology

DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA URINE DRUGS OF ABUSE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODEL AMI1200 C-ARM

FDA 510(k)

FDA Class 2 ·Radiology

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

FDA 510(k)

FDA Class 2 ·Hematology

Avanti Distal Radius and Forearm System

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELS CANNULA (KIT), MODEL M1210-88,M1510-88

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRATUS CS TROPONIN I CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Playtex Stella Tampons

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology