VISOPROTECT OCCULAR SHIELD

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

TDM I LINEARITY TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ALERE PBP2A SA/CONS CULTURE COLONY TEST

FDA 510(k)

FDA Class 2 ·Microbiology

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

FilmArray RP EZ Control Panel M265

FDA 510(k)

FDA Class 2 ·Microbiology

VENTREZYME VAST SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

CytoSure Urinary Access System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

FDA 510(k)

FDA Class 1 ·Microbiology

VENTRESCREEN (TM) MONO

FDA 510(k)

FDA Class 2 ·Immunology

OVOMotion Reverse Shoulder Arthroplasty System

FDA 510(k)

FDA Class 2 ·Orthopedic

LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Puritan Opti-Tranz Cary-Blair Collection and Transport System

FDA 510(k)

FDA Class 1 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR AAT

FDA 510(k)

FDA Class 2 ·Immunology

DOCUMENT TDM ULTRA ASSAYED CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Toxicology

VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICRO SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPQ(TM) ANTIBODY REAGENT SET II FOR C4

FDA 510(k)

FDA Class 2 ·Immunology