Cleared Traditional

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

K191360 · Abbott Point of Care, Inc. · Chemistry
Feb 2020
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K191360 is an FDA 510(k) clearance for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, a Electrode, Ion Specific, Calcium (Class II — Special Controls, product code JFP), submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on February 14, 2020, 269 days after receiving the submission on May 21, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K191360 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2019
Decision Date February 14, 2020
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFP — Electrode, Ion Specific, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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