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)

GO GLUCOSE MONITORING SYSTEM

K-Number: K991754 · 1999-09-08

ApplicantLxn Corp.
Decision Date1999-09-08
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GO GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lxn Corp.. It received FDA 510(k) clearance on 1999-09-08 under 510(k) number K991754. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GO GLUCOSE MONITORING SYSTEM?

GO GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-08. The listed applicant is Lxn Corp.. The 510(k) number is K991754.

When did GO GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

GO GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 1999-09-08, under 510(k) number K991754.

Who is the listed applicant for GO GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for GO GLUCOSE MONITORING SYSTEM?

The FDA product code for GO GLUCOSE MONITORING SYSTEM is CGA.

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 Lxn 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.

K002688PERSONAL GLUCOSE CONTROL CHARTING SYSTEMK990942DUET II GLUCOSE CONTROL MONITORING SYSTEMK973140DUET GLUCOSE CONTROL MONITORING SYSTEMK962597LXN FRUCTOSAMINE TEST SYSTEMK960034LXN BLOOD GLUCOSE TEST SYSTEMK955629LXN FRUCTOSAMINE TEST

View all 7 devices →

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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.

↑