Cleared Traditional

CIBA CORNING 348 SYSTEM

K962021 · Ciba Corning Diagnostics Corp. · Chemistry
Jun 1996
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K962021 is an FDA 510(k) clearance for the CIBA CORNING 348 SYSTEM, a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II — Special Controls, product code CHL), submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on June 24, 1996, 32 days after receiving the submission on May 23, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1120.

Submission Details

510(k) Number K962021 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1996
Decision Date June 24, 1996
Days to Decision 32 days
Submission Type Traditional
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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