FDA 510(k)

UniStrip1 Generic Blood Glucose Test Strips

Número K: K160038 · 2016-07-29

Data da decisão2016-07-29

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do 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 2016-07-29 under 510(k) number K160038. 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.

Perguntas frequentes

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 2016-07-29. The listed applicant is Ok Biotech Co., Ltd.. The 510(k) number is K160038.

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 2016-07-29, under 510(k) number K160038.

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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Outros registros que listam Ok Biotech Co., Ltd. como candidato(a)

K213061SuperCheck Pro Blood Glucose Monitoring System K162430UniStrip1 Generic Blood Glucose Test Strips K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

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