Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SODIUM BICARBONATE, U.S.P.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRX POWER TILT AND RECLINE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

OLYMPUS LACTATE, OSR6193

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH

FDA 510(k)

FDA Class 2 ·Immunology

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

FDA 510(k)

FDA Class 2 ·Hematology

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS

FDA 510(k)

FDA Class 2 ·Physical Medicine

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.

FDA 510(k)

FDA Class 2 ·Immunology

TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT

FDA 510(k)

FDA Class 2 ·Radiology

Neocis Planning Software Application (NPSA) for 3rd Party PCs

FDA 510(k)

FDA Class 2 ·Dental

DISCAM DIGITAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

OXFORD RETRO-ILLUMINATION CATARACT CAMERA

FDA 510(k)

FDA Class 2 ·Ophthalmic

PARAMAX SALICYLATE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology