DADE THROMBIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pepper EMS Training System

FDA 510(k)

FDA Class 2 ·Physical Medicine

CRONEX KEVLAR CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

PT-MULTI-CALIBRATOR, MODEL OPAT07

FDA 510(k)

FDA Class 2 ·Hematology

STRATUS CS MYOGLOBIN (MYO) TESTPAK

FDA 510(k)

FDA Class 2 ·Immunology

PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Gastro Concepts Air Assist

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology