SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bpump Blood Pressure Cuff

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON SYSTEMS LIPID CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Arm automatic blood pressure monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Immunology

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

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC

FDA 510(k)

FDA Class 2 ·Radiology

UNILYTE A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ti3Z Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic