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FDA 510(k)

ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM

K-Number: K950727 · 1995-06-01

ApplicantLifescan, Inc.
Decision Date1995-06-01
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 1995-06-01 under 510(k) number K950727. 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 PROFILE COMPLETE DIABETES TRACKING SYSTEM?

ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-01. The listed applicant is Lifescan, Inc.. The 510(k) number is K950727.

When did ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM receive FDA 510(k) clearance?

ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM received FDA 510(k) clearance on 1995-06-01, under 510(k) number K950727.

Who is the listed applicant for ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM?

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

What is the FDA product code for ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM?

The FDA product code for ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM is CGA.

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Other records listing Lifescan, 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.

K132618ONETOUCH REVEALK120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONK093745ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMK082590SYMPHONY METER REMOTEK082513ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEMK081318ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM

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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.

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