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FDA 510(k)

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION

K-Number: K934900 · 1993-12-07

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-12-07
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION 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 1993-12-07 under 510(k) number K934900. 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 MODIFICATION?

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-12-07. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K934900.

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

GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION received FDA 510(k) clearance on 1993-12-07, under 510(k) number K934900.

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

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 MODIFICATION?

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

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Related Devices (Code: CFR)

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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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