Cleared Traditional

i-STAT CHEM8+ cartridge with the i-STAT 1 System

K183688 · Abbott Point of Care, Inc. · Chemistry
Feb 2020
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K183688 is an FDA 510(k) clearance for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on February 7, 2020, 406 days after receiving the submission on December 28, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K183688 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2018
Decision Date February 07, 2020
Days to Decision 406 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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