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FDA 510(k)

DiaSpect Tm, DiaSpect Tm Cuvettes

K-Number: K172173 · 2018-04-06

ApplicantEkf-Diagnostic GmbH
Decision Date2018-04-06
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DiaSpect Tm, DiaSpect Tm Cuvettes 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 2018-04-06 under 510(k) number K172173. 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 DiaSpect Tm, DiaSpect Tm Cuvettes?

DiaSpect Tm, DiaSpect Tm Cuvettes is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Ekf-Diagnostic GmbH. The 510(k) number is K172173.

When did DiaSpect Tm, DiaSpect Tm Cuvettes receive FDA 510(k) clearance?

DiaSpect Tm, DiaSpect Tm Cuvettes received FDA 510(k) clearance on 2018-04-06, under 510(k) number K172173.

Who is the listed applicant for DiaSpect Tm, DiaSpect Tm Cuvettes?

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 DiaSpect Tm, DiaSpect Tm Cuvettes?

The FDA product code for DiaSpect Tm, DiaSpect Tm Cuvettes is GKR.

Other records listing Ekf-Diagnostic GmbH as applicant

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Official Source

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