FDA 510(k)

TEST, BLOOD GLUCOSE SYSTEM

K-Number: K120064 · 2012-09-05

Decision Date2012-09-05

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TEST, BLOOD GLUCOSE 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 2012-09-05 under 510(k) number K120064. 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 TEST, BLOOD GLUCOSE SYSTEM?

TEST, BLOOD GLUCOSE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-05. The listed applicant is Hmd Biomedical, Inc.. The 510(k) number is K120064.

When did TEST, BLOOD GLUCOSE SYSTEM receive FDA 510(k) clearance?

TEST, BLOOD GLUCOSE SYSTEM received FDA 510(k) clearance on 2012-09-05, under 510(k) number K120064.

Who is the listed applicant for TEST, BLOOD GLUCOSE 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 TEST, BLOOD GLUCOSE SYSTEM?

The FDA product code for TEST, BLOOD GLUCOSE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hmd Biomedical, Inc. as applicant

K212248GlucoLeader Enhance 2 Blood Glucose Monitoring System K182428GlucoLeader Enhance Blood Glucose Monitoring System K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM K032985GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

View all 8 devices →

Related Devices (Code: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care 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 Corporation K240640Sejoy 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.