INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

FDA 510(k)

FDA Class 2 ·Hematology

Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Rainbow LS Pressing

FDA 510(k)

FDA Class 2 ·Dental

SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

rainbow Shine

FDA 510(k)

FDA Class 2 ·Dental

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NRC NON-RINSE CONDITIONER

FDA 510(k)

FDA Class 2 ·Dental

MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT

FDA 510(k)

FDA Class 2 ·Dental

AEGIS PIT & FISSURE SEALANT WITH ACP

FDA 510(k)

FDA Class 2 ·Dental

TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION

FDA 510(k)

FDA Class 2 ·Dental

ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN

FDA 510(k)

FDA Class 2 ·Dental

FISSURE SEALER & BONDING AGENT

FDA 510(k)

FDA Class 2 ·Dental

SEALITE

FDA 510(k)

FDA Class 2 ·Dental