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FDA 510(k)

INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K893404 · 1989-08-03

ApplicantApprise, Inc.
Decision Date1989-08-03
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Apprise, Inc.. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K893404. 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 INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM?

INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Apprise, Inc.. The 510(k) number is K893404.

When did INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 1989-08-03, under 510(k) number K893404.

Who is the listed applicant for INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM is CGA.

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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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