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FDA 510(k)

GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION

K-Number: K951058 · 1995-06-01

ApplicantHeraeus Kulzer, Inc.
Decision Date1995-06-01
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION 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 1995-06-01 under 510(k) number K951058. 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 WORKSTATION?

GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION is a medical device that received FDA 510(k) clearance on 1995-06-01. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K951058.

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

GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION received FDA 510(k) clearance on 1995-06-01, under 510(k) number K951058.

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

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 WORKSTATION?

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

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: CFR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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