Cleared Traditional

i-STAT G cartridge with the i-STAT 1 System

K223755 · Abbott Point of Care, Inc. · Chemistry
Sep 2023
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K223755 is an FDA 510(k) clearance for the i-STAT G cartridge with the i-STAT 1 System, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Abbott Point of Care, Inc. (Princeton, US). The FDA issued a Cleared decision on September 11, 2023, 270 days after receiving the submission on December 15, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K223755 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2022
Decision Date September 11, 2023
Days to Decision 270 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

Similar Devices — CGA Glucose Oxidase, Glucose

All 399
YSI 2900C Biochemistry Analyzer
K210933 · Ysi, Inc. · Sep 2024
EasyStat 300
K220328 · Medica Corporation · Jul 2024
Cholestech LDX ? System
K223179 · Alere San Diego, Inc. · Sep 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · Abbott Point of Care, Inc. · Jul 2023
GEM Premier ChemSTAT
K223090 · Instrumentation Laboratory CO · Jan 2023
Nova Primary Glucose Analyzer System
K203549 · Nova Biomedical Corporation · Oct 2022