Cleared Traditional

i-STAT CG8+ cartridge with the i-STAT 1 System

K230300 · Abbott Point of Care, Inc. · Chemistry
Oct 2023
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K230300 is an FDA 510(k) clearance for the i-STAT CG8+ 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 October 27, 2023, 266 days after receiving the submission on February 3, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K230300 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2023
Decision Date October 27, 2023
Days to Decision 266 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

Similar Devices — JFP Electrode, Ion Specific, Calcium

All 28
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · Abbott Point of Care, Inc. · Feb 2020
Stat Profile Prime ES Comp Plus Analyzer System
K191626 · Nova Biomedical Corporation · Aug 2019
EasyLyte Na/K/Cl/Ca Analyzer
K152327 · Medica Corporation · Dec 2016
AVL OPTI CRITICAL CARE ANALYZER
K984299 · Avl Scientific Corp. · Dec 1998
AVL 9181 ELECTROLYTE ANALYZER
K972673 · Avl Scientific Corp. · Aug 1997
EASYLYTE CALCIUM/CHLORIDE ANALYZER
K963694 · Medica Corp. · Nov 1996