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FDA 510(k)

SELFCHECK GLUCO

K-Number: K061528 · 2006-09-22

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2006-09-22
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SELFCHECK GLUCO is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 2006-09-22 under 510(k) number K061528. 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 SELFCHECK GLUCO?

SELFCHECK GLUCO is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K061528.

When did SELFCHECK GLUCO receive FDA 510(k) clearance?

SELFCHECK GLUCO received FDA 510(k) clearance on 2006-09-22, under 510(k) number K061528.

Who is the listed applicant for SELFCHECK GLUCO?

The FDA 510(k) record lists Card Guard Scientific Survival , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELFCHECK GLUCO?

The FDA product code for SELFCHECK GLUCO is 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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