Cleared Traditional

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK

K912387 · I-Stat Corp. · Chemistry
Jul 1991
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K912387 is an FDA 510(k) clearance for the I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on July 1, 1991, 61 days after receiving the submission on May 1, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K912387 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1991
Decision Date July 01, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGS — Electrode, Ion Specific, Sodium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1665

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