DIASTAT ANTI-JO-1 KIT

FDA 510(k)

FDA Class 2 ·Immunology

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

ES-1000SP II SMART DOP

FDA 510(k)

FDA Class 2 ·Cardiovascular

KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

DIASTAT ENA SINGLE WELL SCREEN KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-MPO (PANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

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

DIASTAT ANTI-PR3 (C-ANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Immunology

DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DS-240 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT ANTI-THYROID PEROXIDASE KIT

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

QUANTASE PHENYLALANINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular