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

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

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION DRUG CALIBRATOR II, MODEL DC49B

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH

FDA 510(k)

FDA Class 2 ·Immunology

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENZYME II CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry