Cleared Traditional

I-STAT TESTS FOR ACID-BASE PARAMETERS

K936081 · I-Stat Corp. · Chemistry
Feb 1994
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K936081 is an FDA 510(k) clearance for the I-STAT TESTS FOR ACID-BASE PARAMETERS, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by I-Stat Corp. (Ontario K2l 1t9, Canada, CA). The FDA issued a Cleared decision on February 24, 1994, 65 days after receiving the submission on December 21, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K936081 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1993
Decision Date February 24, 1994
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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