Atellica® CH Diazo Total Bilirubin (D_TBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH

FDA 510(k)

FDA Class 2 ·Immunology

LightForce LTS Model 1000, 1500, 2500, and 4000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LC THERAPY, MODEL LCT-1000

FDA 510(k)

FDA Class 2 ·Physical Medicine

DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M

FDA 510(k)

FDA Class 2 ·Immunology

COMPRESSOR NEBULIZER MODEL MCN-S600XX

FDA 510(k)

FDA Class 2 ·Anesthesiology

HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DUPONT ALCOHOL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LOCI THYROID CALIBRATOR WITH MODEL RC610

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOBRAMYCIN FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEPARIN ACA ANALYTICAL TEST PACK

FDA 510(k)

FDA Class 2 ·Hematology

F3

FDA 510(k)

FDA Class 2 ·Radiology

Avanti Orthopaedics Ulnar Shortening System

FDA 510(k)

FDA Class 2 ·Orthopedic

MYOGLOBIN FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology

DUPONT SALICYLATE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology