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FDA 510(k)

ONE TOUCH TEST STRIPS

K-Number: K923544 · 1992-12-03

ApplicantLifescan, Inc.
Decision Date1992-12-03
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONE TOUCH TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 1992-12-03 under 510(k) number K923544. 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 TEST STRIPS?

ONE TOUCH TEST STRIPS is a medical device that received FDA 510(k) clearance on 1992-12-03. The listed applicant is Lifescan, Inc.. The 510(k) number is K923544.

When did ONE TOUCH TEST STRIPS receive FDA 510(k) clearance?

ONE TOUCH TEST STRIPS received FDA 510(k) clearance on 1992-12-03, under 510(k) number K923544.

Who is the listed applicant for ONE TOUCH TEST STRIPS?

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 TEST STRIPS?

The FDA product code for ONE TOUCH TEST STRIPS 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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