FDA 510(k)

HemoCue Hb 801 System

K-Number: K181751 · 2019-02-01

Decision Date2019-02-01

Product CodeGKR

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HemoCue Hb 801 System is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue AB. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K181751. 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 Hb 801 System?

HemoCue Hb 801 System is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Hemocue AB. The 510(k) number is K181751.

When did HemoCue Hb 801 System receive FDA 510(k) clearance?

HemoCue Hb 801 System received FDA 510(k) clearance on 2019-02-01, under 510(k) number K181751.

Who is the listed applicant for HemoCue Hb 801 System?

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

What is the FDA product code for HemoCue Hb 801 System?

The FDA product code for HemoCue Hb 801 System is GKR.

Other records listing Hemocue AB 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.

K201217HemoCue Hb 301 System

Related Devices (Code: GKR)

K201217HemoCue Hb 301 SystemHemocue AB K200909Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbH K182298hemochroma PLUS SystemImmunostics Inc.,K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbH K163465hemochroma PLUS SystemImmunostics Inc.,

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.