Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N APOLIPOPROTEIN STANDARD SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONTROL PLASMA N AND CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO STANDARD HUMAN PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

SYVA EMIT II PLUS AMPHETAMINES ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CONTROL PLASMA N, PROC CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

FDA 510(k)

FDA Class 2 ·Hematology

ENZYME II CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONTROL PLASMA N

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISA HBA1C, MODEL K3105A

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 VANCOMYCIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica® CH Diazo Total Bilirubin (D_TBil)

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

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

CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology