JQY — Ph Meter Class I

FDA Device Classification

FDA product code JQY covers "Ph Meter", a Class I medical device regulated under 21 CFR 862.2050. Submissions are reviewed by the Clinical Chemistry panel. At least 8 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JQY
Device Class
Class I
Regulation Number
862.2050
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K952178Diagnostic ReagentsPH-DETECT TESTOct 20, 1995
K905146Diagnostic SystemsOLYMPUS URINE PHFeb 4, 1991
K872888Ciba Corning DiagnosticsCIBA CORNING 288 PH/BLOOD GAS SYSTEMAug 25, 1987
K770347Beckman InstrumentsMETER, PH, DIGITAL, MODEL 3560Apr 15, 1977
K770352Beckman InstrumentsMETER, IV PH, MODEL EXPANDOMATICApr 8, 1977
K770351Beckman InstrumentsMETER, IV PH, MODEL ZEROMATICApr 5, 1977
K760788Corning Medical And ScientificPH METER-125 (.01 PH)Nov 16, 1976
K760789Corning Medical And ScientificPH METER-130 (.001 PH)Nov 16, 1976