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FDA 510(k)

GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM

K-Number: K904081 · 1990-12-26

ApplicantHeraeus Kulzer, Inc.
Decision Date1990-12-26
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM 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 1990-12-26 under 510(k) number K904081. 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 QA BLOOD GLUCOSE METER AND GLUCOFILM?

GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM is a medical device that received FDA 510(k) clearance on 1990-12-26. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K904081.

When did GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM receive FDA 510(k) clearance?

GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM received FDA 510(k) clearance on 1990-12-26, under 510(k) number K904081.

Who is the listed applicant for GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM?

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 QA BLOOD GLUCOSE METER AND GLUCOFILM?

The FDA product code for GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM 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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