FDA 510(k)

UniStrip1 Generic Blood Glucose Test Strips

N.º K: K162430 · 2017-01-19

Fecha de decisión2017-01-19

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

UniStrip1 Generic Blood Glucose Test Strips is the device name listed in this FDA 510(k) record. The listed applicant is Ok Biotech Co., Ltd.. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K162430. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the UniStrip1 Generic Blood Glucose Test Strips?

UniStrip1 Generic Blood Glucose Test Strips is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Ok Biotech Co., Ltd.. The 510(k) number is K162430.

When did UniStrip1 Generic Blood Glucose Test Strips receive FDA 510(k) clearance?

UniStrip1 Generic Blood Glucose Test Strips received FDA 510(k) clearance on 2017-01-19, under 510(k) number K162430.

Who is the listed applicant for UniStrip1 Generic Blood Glucose Test Strips?

The FDA 510(k) record lists Ok Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniStrip1 Generic Blood Glucose Test Strips?

The FDA product code for UniStrip1 Generic Blood Glucose Test Strips is NBW. This falls under the OB/GYN category.

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Otros registros que enlistan a Ok Biotech Co., Ltd. como solicitante

K213061SuperCheck Pro Blood Glucose Monitoring System K160038UniStrip1 Generic Blood Glucose Test Strips K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

Dispositivos relacionados (Código: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Fuente oficial

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