Cleared Traditional

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300

K001387 · I-Stat Corp. · Chemistry
Oct 2000
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K001387 is an FDA 510(k) clearance for the I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on October 5, 2000, 156 days after receiving the submission on May 2, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K001387 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2000
Decision Date October 05, 2000
Days to Decision 156 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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