Cleared Traditional

i-STAT CG4+ Cartridge with the i-STAT 1 System

K200492 · Abbott Point of Care, Inc. · Chemistry
Apr 2020
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K200492 is an FDA 510(k) clearance for the i-STAT CG4+ Cartridge with the i-STAT 1 System, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on April 9, 2020, 41 days after receiving the submission on February 28, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K200492 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2020
Decision Date April 09, 2020
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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