Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COBES SURGICAL DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BentrioTM Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

DIMENSIONS HB1C KIT, MODEL DF105A

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPUS TROPONIN I CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA(R) DIGITOXIN (DGTX) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

N PROTEIN STANDARD UY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PAROJECT ANESTHETIC SYRINGE

FDA 510(k)

FDA Class 2 ·Dental

DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

FDA 510(k)

FDA Class 2 ·Immunology

Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING

FDA 510(k)

FDA Class 2 ·Radiology

HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010

FDA 510(k)

FDA Class 2 ·Cardiovascular

DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID

FDA 510(k)

FDA Class 2 ·Immunology

ACA DIGOXIN ANALYTICAL TEST PACK

FDA 510(k)

FDA Class 2 ·Clinical Toxicology