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FDA 510(k)

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER

K-Number: K926361 · 1993-06-24

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-06-24
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER ENCORE QA 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 1993-06-24 under 510(k) number K926361. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOMETER ENCORE QA BLOOD GLUCOSE METER?

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER is a medical device that received FDA 510(k) clearance on 1993-06-24. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K926361.

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

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER received FDA 510(k) clearance on 1993-06-24, under 510(k) number K926361.

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

The FDA product code for GLUCOMETER ENCORE QA BLOOD GLUCOSE METER is CFR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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