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FDA 510(k)

UniStrip1 Generic Blood Glucose Test Strips

K-Number: K162430 · 2017-01-19

ApplicantOk Biotech Co., Ltd.
Decision Date2017-01-19
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Ok Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213061SuperCheck Pro Blood Glucose Monitoring SystemK160038UniStrip1 Generic Blood Glucose Test StripsK152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

Related Devices (Code: NBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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