ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Alere NT-proBNP for Alinity i Reagent Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling

FDA 510(k)

FDA Class 2 ·Orthopedic

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

AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

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

ULTIMA SNORING MIKE, MODEL 0540

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·Artegraft Collagen Vascular Graft