PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RANDOX DIGOXIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GlucoSure Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BGM014 Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MultiSure GK Link Blood Glucose and Ketone Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAL-1A Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GlucoSure HT Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

InnoSight Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

GlucoSure ADVANCE Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MTM301 Blood Glucose and Ketone Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218

FDA 510(k)

FDA Class 2 ·Cardiovascular

CenterCross Ultra Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIRGO (R) CMV-IGG ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

Z3 GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENABLER-P CATHETER SYSTEM, MODEL 3000

FDA 510(k)

FDA Class 2 ·Cardiovascular