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 a medical device manufactured by Ekf-Diagnostic GmbH. It received FDA 510(k) clearance on 2018-04-06 under approval 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. It is manufactured by Ekf-Diagnostic GmbH. The 510(k) number is K172173.
When was DiaSpect Tm, DiaSpect Tm Cuvettes approved by the FDA?
DiaSpect Tm, DiaSpect Tm Cuvettes received FDA 510(k) clearance on 2018-04-06, under approval number K172173.
What company makes DiaSpect Tm, DiaSpect Tm Cuvettes?
DiaSpect Tm, DiaSpect Tm Cuvettes is manufactured by Ekf-Diagnostic GmbH.
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 Devices by Ekf-Diagnostic GmbH
Related Devices (Code: GKR)
Official Source
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