IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

FDA 510(k)

FDA Class 2 ·Microbiology

VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.

FDA 510(k)

FDA Class 2 ·Dental

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TRU LEGIONELLA

FDA 510(k)

FDA Class 2 ·Microbiology

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

LEGIONELLA STAT IGG/IGM TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

FDA 510(k)

FDA Class 2 ·Microbiology

LEGIONELLA PNEUMOPHILA IGG/IGM

FDA 510(k)

FDA Class 2 ·Microbiology

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

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

1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ETUDE, URODYNAMIC INVESTIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

1512M/F WIRE ELECTRODE NEEDLE SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology