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FDA 510(k)

Hemo Control (optional Add Pack Hemo Control DM)

K-Number: K200909 · 2020-06-12

ApplicantEkf-Diagnostic GmbH
Decision Date2020-06-12
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Hemo Control (optional Add Pack Hemo Control DM) is the device name listed in this FDA 510(k) record. The listed applicant is Ekf-Diagnostic GmbH. It received FDA 510(k) clearance on 2020-06-12 under 510(k) number K200909. 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 Hemo Control (optional Add Pack Hemo Control DM)?

Hemo Control (optional Add Pack Hemo Control DM) is a medical device that received FDA 510(k) clearance on 2020-06-12. The listed applicant is Ekf-Diagnostic GmbH. The 510(k) number is K200909.

When did Hemo Control (optional Add Pack Hemo Control DM) receive FDA 510(k) clearance?

Hemo Control (optional Add Pack Hemo Control DM) received FDA 510(k) clearance on 2020-06-12, under 510(k) number K200909.

Who is the listed applicant for Hemo Control (optional Add Pack Hemo Control DM)?

The FDA 510(k) record lists Ekf-Diagnostic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemo Control (optional Add Pack Hemo Control DM)?

The FDA product code for Hemo Control (optional Add Pack Hemo Control DM) is GKR.

Other records listing Ekf-Diagnostic GmbH 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.

K180509Quo-Test A1c SystemK172173DiaSpect Tm, DiaSpect Tm Cuvettes

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 ABK181751HemoCue 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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