SYSMEX MODEL UF1000I

FDA 510(k)

FDA Class 2 ·Hematology

MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI

FDA 510(k)

FDA Class 2 ·Hematology

CELLTRACKS AUTOPREP SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

FLAME PHOTOMETRY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

SCANSCOPE XT SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody

FDA 510(k)

FDA Class 2 ·Immunology

CELLTRACKS ANALYZER II

FDA 510(k)

FDA Class 2 ·Immunology

OncoMate MSI Dx Analysis System

FDA 510(k)

FDA Class 2 ·Immunology

FORMACLEAR- & MULTIPLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800

FDA 510(k)

FDA Class 2 ·Immunology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR

FDA 510(k)

FDA Class 2 ·Hematology

SPERM SELECT(TM)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FISHVIEW

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX UF-50

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST

FDA 510(k)

FDA Class 2 ·Hematology