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FDA 510(k)

HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801

K-Number: K061047 · 2006-06-08

ApplicantHemocue AB
Decision Date2006-06-08
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue AB. It received FDA 510(k) clearance on 2006-06-08 under 510(k) number K061047. 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 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801?

HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 is a medical device that received FDA 510(k) clearance on 2006-06-08. The listed applicant is Hemocue AB. The 510(k) number is K061047.

When did HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 receive FDA 510(k) clearance?

HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 received FDA 510(k) clearance on 2006-06-08, under 510(k) number K061047.

Who is the listed applicant for HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801?

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 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801?

The FDA product code for HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 is GKR.

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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 SystemK181751HemoCue Hb 801 SystemK071652HEMOCUE WBC SYSTEMK060765HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712K053253HEMOCUE ALBUMIN 201 ANALYZING SYSTEM

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

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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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