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FDA 510(k)

HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM

K-Number: K041234 · 2004-06-10

ApplicantHemocue, Inc.
Decision Date2004-06-10
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue, Inc.. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K041234. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM?

HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Hemocue, Inc.. The 510(k) number is K041234.

When did HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM receive FDA 510(k) clearance?

HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM received FDA 510(k) clearance on 2004-06-10, under 510(k) number K041234.

Who is the listed applicant for HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM?

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

What is the FDA product code for HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM?

The FDA product code for HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM is GKR.

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Other records listing Hemocue, Inc. as applicant

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.

K041230CLINICAL LABORATORY ANALYZING SYSTEMK032203HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704K020935HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706K962415HEMOCUE B-GLCOSE SYSTEMK961312HEMOCUE B-HEMOGLOBIN SYSTEMK961311HEMOCUE B-GLUCOSE SYSTEM

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Related Devices (Code: GKR)

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.

K201217HemoCue Hb 301 SystemHemocue ABK200909Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbHK181751HemoCue Hb 801 SystemHemocue ABK182298hemochroma PLUS SystemImmunostics Inc.,K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbHK163465hemochroma PLUS SystemImmunostics Inc.,

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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