Cleared Traditional

SmartLyte? Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

K200544 · Diamond Diagnostics, Inc. · Chemistry
Oct 2020
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K200544 is an FDA 510(k) clearance for the SmartLyte? Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on October 1, 2020, 212 days after receiving the submission on March 3, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K200544 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2020
Decision Date October 01, 2020
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEM — Electrode, Ion Specific, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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