EXL ANEM CAL, MODEL RC640

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica CH Amylase_2 (AMY_2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LOCI Total Vitamin D Total Assay, LOCI VITD CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG

FDA 510(k)

FDA Class 2 ·Immunology

Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSIONS HB1C KIT, MODEL DF105A

FDA 510(k)

FDA Class 2 ·Hematology

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

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION CHEMISTRY III CALIBRATORY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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