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FDA 510(k)

GlucoLeader Enhance Blood Glucose Monitoring System

K-Number: K182428 · 2019-05-08

ApplicantHmd Biomedical, Inc.
Decision Date2019-05-08
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GlucoLeader Enhance Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2019-05-08 under 510(k) number K182428. 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 GlucoLeader Enhance Blood Glucose Monitoring System?

GlucoLeader Enhance Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-05-08. The listed applicant is Hmd Biomedical, Inc.. The 510(k) number is K182428.

When did GlucoLeader Enhance Blood Glucose Monitoring System receive FDA 510(k) clearance?

GlucoLeader Enhance Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-05-08, under 510(k) number K182428.

Who is the listed applicant for GlucoLeader Enhance Blood Glucose Monitoring System?

The FDA 510(k) record lists Hmd Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GlucoLeader Enhance Blood Glucose Monitoring System?

The FDA product code for GlucoLeader Enhance Blood Glucose 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.

NCT07686939Clinical Validation of Continuous Glucose Monitoring in Glycemic Management of Critically Ill Sepsis PatientsCOMPLETED

Other records listing Hmd Biomedical, Inc. 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.

K212248GlucoLeader Enhance 2 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

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

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