Cleared Dual Track

Quo-Test A1c System

K180509 · Ekf Diagnostic GmbH · Chemistry
Feb 2019
Decision
354d
Days
Class 2
Risk

About This 510(k) Submission

K180509 is an FDA 510(k) clearance for the Quo-Test A1c System, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Ekf Diagnostic GmbH (Barleben, DE). The FDA issued a Cleared decision on February 16, 2019, 354 days after receiving the submission on February 27, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K180509 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2018
Decision Date February 16, 2019
Days to Decision 354 days
Submission Type Dual Track
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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