990 results · 24ms · Sources: EU EUDAMED, US FDA

COULTER Z2 ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology

ERMA PC-604 BLOOD CELL COUNTER

FDA 510(k)
FDA Class 2 ·Hematology

COULTER VOLUME ADAPTER

FDA 510(k)
FDA Class 2 ·Hematology

HEMALOG 8/90

FDA 510(k)
FDA Class 2 ·Hematology

DIGICELL 500

FDA 510(k)
FDA Class 2 ·Hematology

PLATELET COUNTER & HEMATOCRIT ACCES.

FDA 510(k)
FDA Class 2 ·Hematology

THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY

FDA 510(k)
FDA Class 2 ·Hematology

COULTER COUNTER MODEL T-890

FDA 510(k)
FDA Class 2 ·Hematology

COULTER COUNTER M2

FDA 510(k)
FDA Class 2 ·Hematology

TECHNICON H*1 JR.(TM) SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

Counter, Cell, Automated (Particle Counter)

FDA classification
FDA Class 2 ·Counter, Cell, Automated (Particle Counter)

GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GAL-PUT CONTROLS, NORMAL&DEFICIENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

FDA 510(k)
FDA Class 2 ·Immunology

GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

QUANTASE PHE/GAL SCREENING ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VARIOUS SURGICAL OR PATIENT DRAPES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GAL-1A BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry