Ph Meter
The pH Meter is a clinical laboratory instrument used to measure the hydrogen ion concentration (pH) of biological specimens, reagents, and solutions, essential for quality control of reagent preparation, verification of specimen integrity, and certain diagnostic measurements in clinical chemistry laboratories. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JQY and is regulated under 21 CFR 862.2050, within the Clinical Chemistry medical specialty. This device is GMP exempt.
Research product code JQY in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JQY
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952178 | PH-DETECT TEST | Oct 20, 1995 | Substantially Equivalent | Diagnostic Reagents, Inc. |
| K905146 | OLYMPUS URINE PH | Feb 04, 1991 | Substantially Equivalent | Diagnostic Systems |
| K872888 | CIBA CORNING 288 PH/BLOOD GAS SYSTEM | Aug 25, 1987 | Substantially Equivalent | Ciba Corning Diagnostics Corp. |
| K770347 | METER, PH, DIGITAL, MODEL 3560 | Apr 15, 1977 | Substantially Equivalent | Beckman Instruments, Inc. |
| K770352 | METER, IV PH, MODEL EXPANDOMATIC | Apr 08, 1977 | Substantially Equivalent | Beckman Instruments, Inc. |
| K770351 | METER, IV PH, MODEL ZEROMATIC | Apr 05, 1977 | Substantially Equivalent | Beckman Instruments, Inc. |
| K760789 | PH METER-130 (.001 PH) | Nov 16, 1976 | Substantially Equivalent | Corning Medical & Scientific |
| K760788 | PH METER-125 (.01 PH) | Nov 16, 1976 | Substantially Equivalent | Corning Medical & Scientific |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.