DIMENSION CHEMISTRY III CALIBRATORY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

LINQ II Insertable Cardiac Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rickettsia Real-time PCR Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

FDA 510(k)

FDA Class 2 ·Immunology