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FDA 510(k)

ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K021943 · 2002-06-28

ApplicantLifescan, Inc.
Decision Date2002-06-28
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONETOUCH PROFILE BLOOD GLUCOSE MONITORING 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 2002-06-28 under 510(k) number K021943. 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 ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM?

ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-28. The listed applicant is Lifescan, Inc.. The 510(k) number is K021943.

When did ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2002-06-28, under 510(k) number K021943.

Who is the listed applicant for ONETOUCH PROFILE BLOOD GLUCOSE MONITORING 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 ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ONETOUCH PROFILE BLOOD GLUCOSE MONITORING 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.

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Related Devices (Code: CGA)

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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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