Cleared Traditional

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

K210958 · Abbott Point of Care, Inc. · Chemistry
Aug 2021
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K210958 is an FDA 510(k) clearance for the i-STAT CHEM8+ 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. (Princton, US). The FDA issued a Cleared decision on August 13, 2021, 135 days after receiving the submission on March 31, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K210958 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2021
Decision Date August 13, 2021
Days to Decision 135 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

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