FDA product code JQY: Ph Meter
JQY is the FDA product code for ph meter. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under JQY, from 5 different applicants. The average 510(k) review took 69 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Ph Meter |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JQY clearance
Top JQY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 3 | 1977-04-15 |
| Corning Medical & Scientific | 2 | 1976-11-16 |
| Diagnostic Reagents, Inc. | 1 | 1995-10-20 |
| Diagnostic Systems | 1 | 1991-02-04 |
| Ciba Corning Diagnostics Corp. | 1 | 1987-08-25 |
Most recent JQY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952178 | Diagnostic Reagents, Inc. | PH-DETECT TEST | 1995-10-20 | 164 |
| K905146 | Diagnostic Systems | OLYMPUS URINE PH | 1991-02-04 | 81 |
| K872888 | Ciba Corning Diagnostics Corp. | CIBA CORNING 288 PH/BLOOD GAS SYSTEM | 1987-08-25 | 33 |
| K770347 | Beckman Instruments, Inc. | METER, PH, DIGITAL, MODEL 3560 | 1977-04-15 | 52 |
| K770352 | Beckman Instruments, Inc. | METER, IV PH, MODEL EXPANDOMATIC | 1977-04-08 | 45 |
Recalls for JQY devices
openFDA lists no recalls for product code JQY.
Frequently asked questions
What is FDA product code JQY?
JQY is the FDA product code for ph meter. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JQY?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQY?
Across 8 cleared submissions the average was 69 days from receipt to decision (median 60).
Which companies have the most JQY clearances?
Beckman Instruments, Inc. (3); Corning Medical & Scientific (2); Diagnostic Reagents, Inc. (1); Diagnostic Systems (1); Ciba Corning Diagnostics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQY
- Run a recall and safety report across every JQY manufacturer
- Watch product code JQY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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