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FDA 510(k)

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650

K-Number: K120423 · 2012-08-03

ApplicantBionime Corporation
Decision Date2012-08-03
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2012-08-03 under 510(k) number K120423. 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 BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650?

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 is a medical device that received FDA 510(k) clearance on 2012-08-03. The listed applicant is Bionime Corporation. The 510(k) number is K120423.

When did BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 receive FDA 510(k) clearance?

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 received FDA 510(k) clearance on 2012-08-03, under 510(k) number K120423.

Who is the listed applicant for BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650?

The FDA 510(k) record lists Bionime Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650?

The FDA product code for BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 is NBW. This falls under the OB/GYN category.

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Other records listing Bionime Corporation 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.

K240637RIGHTEST Blood Glucose Monitoring System Max TelK231192RIGHTEST Blood Glucose Monitoring System Max TelK221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceK190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SBK173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max PlusK173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus

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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.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE 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.

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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