TRU Legionella

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX LEGIONELLA URINARY ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

Helix Genetic Health Risk App for late-onset Alzheimer’s disease

FDA 510(k)

FDA Class 2 ·Immunology

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

FDA 510(k)

FDA Class 2 ·Microbiology

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.

FDA 510(k)

FDA Class 2 ·Microbiology

SAS BRUCELLA SUIS ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS BRUCELLA MELITENSIS ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS BRUCELLA AMS ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA

FDA 510(k)

FDA Class 2 ·Microbiology

ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE

FDA 510(k)

FDA Class 2 ·Microbiology

SAS BRUCELLAS ABORTUS ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

LEPTOSPIROSIS IHA

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SAS SALMONELLA H U ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology