ID-Cap System

FDA 510(k)

FDA Class 2 ·General Hospital

IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR

FDA 510(k)

FDA Class 2 ·Immunology

IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRON CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB

FDA 510(k)

FDA Class 2 ·Immunology

SYNCHRON SYSTEMS AMMONIA REAGENT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204657·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204671·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204633·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204640·Endoscopic Biliary Endoprosthesis

WALLSTENT™ BILIARY

FDA UDI

BOSTON SCIENTIFIC CORPORATION·08714729204664·Endoscopic Biliary Endoprosthesis