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

DRUG CALIBRATOR II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)

FDA 510(k)

FDA Class 2 ·Radiology

DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

CAMPION CERVICAL HOOK

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PERMACEM / PERMACEM DUAL

FDA 510(k)

FDA Class 2 ·Dental