Clarify DL

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

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

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

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

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

ST AIA-PACK PROG II Calibrator Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-EIA DIAGNOSTIC TEST KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

MODEL EB-22 NOISE STIK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat