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

URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OFNat Lubricant (L15)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Microthin Natural Rubber Latex Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RADIOPAQUE BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

PHOENIX 3.25 MM HA COATED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery