Cleared Traditional

CIBA CORNING 288 PH/BLOOD GAS SYSTEM

K872888 · Ciba Corning Diagnostics Corp. · Chemistry
Aug 1987
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K872888 is an FDA 510(k) clearance for the CIBA CORNING 288 PH/BLOOD GAS SYSTEM, a Ph Meter (Class I — General Controls, product code JQY), submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on August 25, 1987, 33 days after receiving the submission on July 23, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K872888 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1987
Decision Date August 25, 1987
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQY — Ph Meter
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050