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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

FDA 510(k)

FDA Class 2 ·Immunology

FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)

FDA Class 2 ·Immunology

DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

FDA 510(k)

FDA Class 2 ·Hematology

ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

ISAAC 1.5 T MR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Elcam Stopcocks and Manifolds

FDA 510(k)

FDA Class 2 ·General Hospital

SafePort(TM) Manifold (or Stopcock)

FDA 510(k)

FDA Class 2 ·General Hospital

ELCAM STOPCOCKS AND MANIFOLDS

FDA 510(k)

FDA Class 2 ·General Hospital

INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)

FDA 510(k)

FDA Class 2 ·General Hospital

A-TAP (previously called Arthrotap)

FDA 510(k)

FDA Class 2 ·General Hospital