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FDA 510(k)

EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP

K-Number: K991480 · 1999-09-17

ApplicantSelfcare, Inc.
Decision Date1999-09-17
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Selfcare, Inc.. It received FDA 510(k) clearance on 1999-09-17 under 510(k) number K991480. 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 EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP?

EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP is a medical device that received FDA 510(k) clearance on 1999-09-17. The listed applicant is Selfcare, Inc.. The 510(k) number is K991480.

When did EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP receive FDA 510(k) clearance?

EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP received FDA 510(k) clearance on 1999-09-17, under 510(k) number K991480.

Who is the listed applicant for EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP?

The FDA 510(k) record lists Selfcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP?

The FDA product code for EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP is CGA.

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Other records listing Selfcare, 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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