Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K130244 · 2013-08-23

ApplicantDelbio Incorporation
Decision Date2013-08-23
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Delbio Incorporation. It received FDA 510(k) clearance on 2013-08-23 under 510(k) number K130244. 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 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM?

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-23. The listed applicant is Delbio Incorporation. The 510(k) number is K130244.

When did DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2013-08-23, under 510(k) number K130244.

Who is the listed applicant for DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for DIATRUE PLUS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Delbio Incorporation 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.

K132338DA01 BLOOD GLUCOSE MONITORING SYSTEMK120866DA01 BLOOD GLUCOSE MONITORING SYSTEMK103329DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTIONK113343DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEMK100806DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM

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.

↑