FDA 510(k)

DiaSpect Tm, DiaSpect Tm Cuvettes

K号: K172173 · 2018-04-06

决定日期2018-04-06

产品代码GKR

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决定实质等同

器械摘要

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.

常见问题

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.

列明Ekf-Diagnostic GmbH为申报人的其他记录

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