Ciba Corning 288 Ph/Blood Gas System

FDA 510(k) K872888 · Ciba Corning Diagnostics Corp.

Substantially Equivalent

510(k) numberK872888

Submission

Device name
Ciba Corning 288 Ph/Blood Gas System
Applicant
Ciba Corning Diagnostics Corp.
East Walpole, MA, US
Received
July 23, 1987
Decision date
August 25, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JQY – Ph Meter
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Specialty
Clinical Chemistry

Other 510(k)s with product code JQY

510(k)DeviceApplicantDecision
K952178Ph-Detect TestJQY · Traditional Diagnostic Reagents, Inc.10/20/1995SE
K905146Olympus Urine PHJQY · Traditional Diagnostic Systems02/04/1991SE
K770347Meter, PH, Digital, Model 3560JQY · Traditional Beckman Instruments, Inc.04/15/1977SE
K770352Meter, IV PH, Model ExpandomaticJQY · Traditional Beckman Instruments, Inc.04/08/1977SE
K770351Meter, IV PH, Model ZeromaticJQY · Traditional Beckman Instruments, Inc.04/05/1977SE
K760789PH METER-130 (.001 PH)JQY · Traditional Corning Medical & Scientific11/16/1976SE
K760788PH METER-125 (.01 PH)JQY · Traditional Corning Medical & Scientific11/16/1976SE

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Questions and answers

When was Ciba Corning 288 Ph/Blood Gas System cleared by the FDA?

Ciba Corning 288 Ph/Blood Gas System (K872888) received a 510(k) decision of Substantially Equivalent on August 25, 1987, 33 days after the submission was received.

What is the product code of K872888?

The FDA product code is JQY – Ph Meter, a Class I (low risk) device regulated under 21 CFR 862.2050.