DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

PHOENIX 3.25 MM HA COATED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS

FDA 510(k)

FDA Class 2 ·Dental

ANGLED 3.25 MM DENTAL IMPLANT ATTACHMENTS

FDA 510(k)

FDA Class 2 ·Dental

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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