Cleared Abbreviated

DC-UIBC-CAL

K163078 · Sekisui Diagnostics P.E.I., Inc. · Chemistry
Dec 2016
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K163078 is an FDA 510(k) clearance for the DC-UIBC-CAL, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown,, CA). The FDA issued a Cleared decision on December 8, 2016, 35 days after receiving the submission on November 3, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K163078 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2016
Decision Date December 08, 2016
Days to Decision 35 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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