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FDA 510(k)

ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K011479 · 2001-11-30

ApplicantInverness Medical Innovations, Inc.
Decision Date2001-11-30
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Inverness Medical Innovations, Inc.. It received FDA 510(k) clearance on 2001-11-30 under 510(k) number K011479. 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 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM?

ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-11-30. The listed applicant is Inverness Medical Innovations, Inc.. The 510(k) number is K011479.

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

ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2001-11-30, under 510(k) number K011479.

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

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

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

The FDA product code for ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM is CGA.

Related Clinical Trials

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Other records listing Inverness Medical Innovations, 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.

K071265SMARTCHECK INR SYSTEMK071587ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAYK060133ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SETK053196ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)K011616INDUO BLOOD GLUCOSE METER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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