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

DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SteriZign Signatur Device Protection System

FDA 510(k)

FDA Class 2 ·General Hospital

BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST

FDA 510(k)

FDA Class 1 ·Microbiology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

FDA 510(k)

FDA Class 2 ·Microbiology

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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

DOCUMENT ENZYME LINEARITY TEST SETS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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

MODIFICATION TO DOCUMENT THYROID CAL.VER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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

DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry