Cleared Special

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

K012478 · I-Stat Corp. · Chemistry
Aug 2001
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K012478 is an FDA 510(k) clearance for the MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by I-Stat Corp. (East Windsor, US). The FDA issued a Cleared decision on August 20, 2001, 18 days after receiving the submission on August 2, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K012478 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2001
Decision Date August 20, 2001
Days to Decision 18 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1120

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