JQY · Ph Meter
Clinical Chemistry · 21 CFR 862.2050 · Class 1
Overview
| Product Code | JQY |
|---|---|
| Device Name | Ph Meter |
| Regulation | 21 CFR 862.2050 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| GMP Exempt | Yes |
Identification
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Classification Rationale
Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952178 | PH-DETECT TEST | Diagnostic Reagents, Inc. | Oct 20, 1995 | SESE |
| K905146 | OLYMPUS URINE PH | Diagnostic Systems | Feb 4, 1991 | SESE |
| K872888 | CIBA CORNING 288 PH/BLOOD GAS SYSTEM | Ciba Corning Diagnostics Corp. | Aug 25, 1987 | SESE |
| K770347 | METER, PH, DIGITAL, MODEL 3560 | Beckman Instruments, Inc. | Apr 15, 1977 | SESE |
| K770352 | METER, IV PH, MODEL EXPANDOMATIC | Beckman Instruments, Inc. | Apr 8, 1977 | SESE |
| K770351 | METER, IV PH, MODEL ZEROMATIC | Beckman Instruments, Inc. | Apr 5, 1977 | SESE |
| K760789 | PH METER-130 (.001 PH) | Corning Medical & Scientific | Nov 16, 1976 | SESE |
| K760788 | PH METER-125 (.01 PH) | Corning Medical & Scientific | Nov 16, 1976 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 3 clearances
- Corning Medical & Scientific — 2 clearances
- Ciba Corning Diagnostics Corp. — 1 clearance
- Diagnostic Reagents, Inc. — 1 clearance
- Diagnostic Systems — 1 clearance
