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FDA 510(k)

GLUCOSCAN TEST STRIPS

K-Number: K822697 · 1982-09-30

ApplicantLifescan, Inc.
Decision Date1982-09-30
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSCAN 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 1982-09-30 under 510(k) number K822697. 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 GLUCOSCAN TEST STRIPS?

GLUCOSCAN TEST STRIPS is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Lifescan, Inc.. The 510(k) number is K822697.

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

GLUCOSCAN TEST STRIPS received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822697.

Who is the listed applicant for GLUCOSCAN 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 GLUCOSCAN TEST STRIPS?

The FDA product code for GLUCOSCAN 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)

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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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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