PH METER-125 (.01 PH)

FDA 510(k) K760788 · Corning Medical & Scientific

Substantially Equivalent

510(k) numberK760788

Submission

Device name
PH METER-125 (.01 PH)
Applicant
Corning Medical & Scientific
Mchenry, IL, US
Received
September 10, 1976
Decision date
November 16, 1976
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
K872888Ciba Corning 288 Ph/Blood Gas SystemJQY · Traditional Ciba Corning Diagnostics Corp.08/25/1987SE
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

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Questions and answers

When was PH METER-125 (.01 PH) cleared by the FDA?

PH METER-125 (.01 PH) (K760788) received a 510(k) decision of Substantially Equivalent on November 16, 1976, 67 days after the submission was received.

What is the product code of K760788?

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