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)

ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K002134 · 2000-08-07

ApplicantSelfcare, Inc.
Decision Date2000-08-07
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Selfcare, Inc.. It received FDA 510(k) clearance on 2000-08-07 under 510(k) number K002134. 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 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM?

ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-07. The listed applicant is Selfcare, Inc.. The 510(k) number is K002134.

When did ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2000-08-07, under 510(k) number K002134.

Who is the listed applicant for ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ONE TOUCH ULTRA BLOOD 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 Selfcare, 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.

K002867INVERNESS MEDICAL OVULATION PREDICTOR TESTK002049INVERNESS MEDICAL EARLY PREGNANCY TESTK001427MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK000583FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK993632FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEMK991480EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP

View all 15 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.

↑