System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

STARLIGHT, MODEL PD9012

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK CEA CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK PROG III Calibrator Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIA-PACK FER CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK DHEA-S CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ST AIA-PACK CYSTATIN C, MODEL 025217

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ST AIA-PACK PROG II Calibrator Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THE DIVACUP MENSTRUAL SOLUTION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA TEST KIT

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M EIA DIAGNOSTIC KIT

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA LABELING CHANGE