Cleared Traditional

DiaSpect Tm, DiaSpect Tm Cuvettes

K172173 · Ekf Diagnostic GmbH · Hematology
Apr 2018
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K172173 is an FDA 510(k) clearance for the DiaSpect Tm, DiaSpect Tm Cuvettes, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Ekf Diagnostic GmbH (Barleben, DE). The FDA issued a Cleared decision on April 6, 2018, 261 days after receiving the submission on July 19, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number K172173 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2017
Decision Date April 06, 2018
Days to Decision 261 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKR — System, Hemoglobin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5620