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)

MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100

K-Number: K011233 · 2001-05-18

ApplicantApex BioTechnology Corp.
Decision Date2001-05-18
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 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 2001-05-18 under 510(k) number K011233. 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 MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100?

MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K011233.

When did MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 receive FDA 510(k) clearance?

MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 received FDA 510(k) clearance on 2001-05-18, under 510(k) number K011233.

Who is the listed applicant for MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100?

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 MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100?

The FDA product code for MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 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 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

View all 30 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.

↑