Cleared Traditional

I-STAT SYSTEM

K011478 · I-Stat Corp. · Chemistry
Jul 2001
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K011478 is an FDA 510(k) clearance for the I-STAT SYSTEM, a Acid, Lactic, Enzymatic Method (Class I — General Controls, product code KHP), submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on July 2, 2001, 49 days after receiving the submission on May 14, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1450.

Submission Details

510(k) Number K011478 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2001
Decision Date July 02, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHP — Acid, Lactic, Enzymatic Method
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1450

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