Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

MONOCLONAL ANTIBODY ANTI-CD5

FDA 510(k)

FDA Class 2 ·Hematology

RDW AND MPV INDICES ON HEMAT 12

FDA 510(k)

FDA Class 2 ·Hematology

UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

XW-100 Automated Hematology Analyzer, XW QC CHECK

FDA 510(k)

FDA Class 2 ·Hematology

FALCON IVF ONE WELL DISH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GENX CULTURE DISH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION

FDA 510(k)

FDA Class 2 ·Hematology

PICSI SPERM SELECTION DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES

FDA 510(k)

FDA Class 2 ·Hematology

TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY

FDA 510(k)

FDA Class 2 ·Hematology

TECHNICON C/90 SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

BIOVATION K-MANAGER

FDA 510(k)

FDA Class 2 ·Hematology

COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526

FDA 510(k)

FDA Class 2 ·Hematology

MOUSE IGG1 NEGATIVE CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

PROINSERT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)

FDA 510(k)

FDA Class 2 ·Hematology