Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROTEIN S AC

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 VANCOMYCIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOCI 8 CALIBRATOR, MODEL KC 646

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

JSA REPROCESSED COMPRESSION SLEEVE DEVICES

FDA 510(k)

FDA Class 2 ·Cardiovascular

OT EQUATOR

FDA 510(k)

FDA Class 2 ·Dental

PHADEBACT MONOCLONAL GC TEST, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

CARDIOMET 4000 GAS MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTINUCATH

FDA 510(k)

FDA Class 2 ·Anesthesiology

MONO-LATEX (TM) SLIDE TEST

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OT EQUATOR

FDA 510(k)

FDA Class 2 ·Dental

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

FDA 510(k)

FDA Class 2 ·Immunology