Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·IMX HAVAB-M

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-RIA MONOCLONAL

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M (R) EIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M DIAGNOSTIC KIT

i-STAT CG4+ cartridge with the i-STAT 1 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

i-STAT CHEM8+ cartridge with the i-STAT 1 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

i-STAT CG8+ cartridge with the i-STAT 1 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

i-STAT Alinity System with i-STAT Sodium test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

I-STAT 1 WIRELESS ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXIFLO ENTERAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

i-STAT hs-TnI cartridge with the i-STAT 1 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

i-STAT CG8+ cartridge with the i-STAT 1 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

i-STAT CHEM8+ cartridge with the i-STAT 1 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry