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FDA 510(k)

GLUCOSCAN METER MODEL II

K-Number: K822699 · 1982-11-05

ApplicantLifescan, Inc.
Decision Date1982-11-05
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSCAN METER MODEL II is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K822699. 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 METER MODEL II?

GLUCOSCAN METER MODEL II is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Lifescan, Inc.. The 510(k) number is K822699.

When did GLUCOSCAN METER MODEL II receive FDA 510(k) clearance?

GLUCOSCAN METER MODEL II received FDA 510(k) clearance on 1982-11-05, under 510(k) number K822699.

Who is the listed applicant for GLUCOSCAN METER MODEL II?

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 METER MODEL II?

The FDA product code for GLUCOSCAN METER MODEL II is CGA.

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Other records listing Lifescan, Inc. as applicant

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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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