HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ADVIA Centaur Calcitonin (CALCT) assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COATEST(R) APC(TM) RESISTANCE

FDA 510(k)

FDA Class 2 ·Hematology

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

FDA 510(k)

FDA Class 2 ·Hematology

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

FDA 510(k)

FDA Class 2 ·Immunology

HANAROSTENT BILIARY (NNN)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Erythropoietin (EPO) assay

FDA 510(k)

FDA Class 2 ·Hematology

C-MOR VISUALIZATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

AFINION ACR AND ACR CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT Active-B12 (Holotranscobalamin)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

FDA 510(k)

FDA Class 2 ·Immunology

MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC

FDA 510(k)

FDA Class 2 ·Radiology

Axis Charcot Fixation System, 4.5 to 8.5mm Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic