Cleared Traditional

I-STAT SYSTEM

K973292 · I-Stat Corp. · Chemistry
Oct 1997
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K973292 is an FDA 510(k) clearance for the I-STAT SYSTEM, a Electrode, Ion Based, Enzymatic, Creatinine (Class II — Special Controls, product code CGL), submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on October 20, 1997, 48 days after receiving the submission on September 2, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K973292 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1997
Decision Date October 20, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGL — Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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