Cleared Traditional

Alinity c ICT Sample Diluent

K170320 · Abbott Laboratories · Chemistry
Oct 2017
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K170320 is an FDA 510(k) clearance for the Alinity c ICT Sample Diluent, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 24, 2017, 265 days after receiving the submission on February 1, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K170320 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2017
Decision Date October 24, 2017
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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