PH-DETECT TEST
FDA 510(k) clearance K952178 · decided 1995-10-20
Clearance details
- K-number
- K952178
- Device name
- PH-DETECT TEST
- Applicant
- Diagnostic Reagents, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-09
- Decision date
- 1995-10-20
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- JQY
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OLYMPUS URINE PH (K905146) | Diagnostic Systems | 1991-02-04 |
| CIBA CORNING 288 PH/BLOOD GAS SYSTEM (K872888) | Ciba Corning Diagnostics Corp. | 1987-08-25 |
| METER, PH, DIGITAL, MODEL 3560 (K770347) | Beckman Instruments, Inc. | 1977-04-15 |
| METER, IV PH, MODEL EXPANDOMATIC (K770352) | Beckman Instruments, Inc. | 1977-04-08 |
| METER, IV PH, MODEL ZEROMATIC (K770351) | Beckman Instruments, Inc. | 1977-04-05 |
| PH METER-130 (.001 PH) (K760789) | Corning Medical & Scientific | 1976-11-16 |
| PH METER-125 (.01 PH) (K760788) | Corning Medical & Scientific | 1976-11-16 |
Recalls involving this device
No recalls on record reference this clearance.