46 results · 27ms · Sources: EU EUDAMED, US FDA

BIONIKE AQ BARBITURATE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ADVANCED QUALITY PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIONIKE A/Q PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIONIKE A/Q PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIONIKE A/Q PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AQ OPIATES (MORPHINE) TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

AQ ONE STEP COCAINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

THE BIONIC EXERCISER

FDA 510(k)
FDA Class 2 ·Neurology

BIONICS ARTERIAL/VENOUS FISTULA NEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BIONIC-TOOTH-PLANT MODEL A-1

FDA 510(k)
FDA Class 2 ·Dental

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CONTACT LENS WITH COLOR ADDITIVE

FDA 510(k)
FDA Class 2 ·Ophthalmic

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650

FDA 510(k)
FDA Class 2 ·Clinical Chemistry