VALIDATE D-Dimer Calibration Verification/Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

SteriZign Signatur Device Protection System

FDA 510(k)

FDA Class 2 ·General Hospital

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

FDA 510(k)

FDA Class 2 ·Microbiology

FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

BioFire JI Control Panel M420

FDA 510(k)

FDA Class 2 ·Microbiology

MICRO MPM

FDA 510(k)

FDA Class 2 ·Anesthesiology

BESPA Charcot System

FDA 510(k)

FDA Class 2 ·Orthopedic

VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ID NOW Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

FLIPSCREEN (TM) TOTAL E IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

VALIDATE Heparin Calibration Verification/Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120

FDA 510(k)

FDA Class 2 ·General Hospital

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

FDA 510(k)

FDA Class 2 ·Microbiology

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

BINAXNOW INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)

FDA Class 2 ·Microbiology

VISIONLINK INTERFILE CONVERSION SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology