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FDA 510(k)

GLUCOMETER GX BLOOD GLUCOSE METER

K-Number: K897015 · 1990-03-29

ApplicantHeraeus Kulzer, Inc.
Decision Date1990-03-29
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER GX BLOOD GLUCOSE METER is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1990-03-29 under 510(k) number K897015. 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 GLUCOMETER GX BLOOD GLUCOSE METER?

GLUCOMETER GX BLOOD GLUCOSE METER is a medical device that received FDA 510(k) clearance on 1990-03-29. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K897015.

When did GLUCOMETER GX BLOOD GLUCOSE METER receive FDA 510(k) clearance?

GLUCOMETER GX BLOOD GLUCOSE METER received FDA 510(k) clearance on 1990-03-29, under 510(k) number K897015.

Who is the listed applicant for GLUCOMETER GX BLOOD GLUCOSE METER?

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

What is the FDA product code for GLUCOMETER GX BLOOD GLUCOSE METER?

The FDA product code for GLUCOMETER GX BLOOD GLUCOSE METER is CGA.

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Other records listing Heraeus Kulzer, 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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