Cleared Traditional

I-STAT 1 WIRELESS ANALYZER

K103195 · Abbott Point of Care, Inc. · Chemistry
Feb 2011
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K103195 is an FDA 510(k) clearance for the I-STAT 1 WIRELESS ANALYZER, 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 February 8, 2011, 102 days after receiving the submission on October 29, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K103195 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2010
Decision Date February 08, 2011
Days to Decision 102 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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