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FDA 510(k)

MultiSure GK Link Blood Glucose and Ketone Monitoring System

K-Number: K201880 · 2021-10-15

ApplicantApex BioTechnology Corp.
Decision Date2021-10-15
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MultiSure GK Link Blood Glucose and Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K201880. 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 MultiSure GK Link Blood Glucose and Ketone Monitoring System?

MultiSure GK Link Blood Glucose and Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K201880.

When did MultiSure GK Link Blood Glucose and Ketone Monitoring System receive FDA 510(k) clearance?

MultiSure GK Link Blood Glucose and Ketone Monitoring System received FDA 510(k) clearance on 2021-10-15, under 510(k) number K201880.

Who is the listed applicant for MultiSure GK Link Blood Glucose and Ketone Monitoring System?

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

What is the FDA product code for MultiSure GK Link Blood Glucose and Ketone Monitoring System?

The FDA product code for MultiSure GK Link Blood Glucose and Ketone Monitoring System is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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.

NCT06977633Feasibility Study of a Continuous Glucose-Ketone Monitoring Device in People With Type 1 DiabetesNOT_YET_RECRUITING

Other records listing Apex BioTechnology Corp. 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.

K242209UASure II Blood Uric Acid Monitoring SystemK222234GlucoSure ADVANCE Link Blood Glucose Monitoring SystemK220421BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring SystemK212140GlucoSure Link Blood Glucose Monitoring SystemK202534MTM301 Blood Glucose and Ketone Monitoring SystemK213887GAL-1A Plus Blood Glucose Monitoring System

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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.

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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