510(k) K905146
- Device
- OLYMPUS URINE PH
- Applicant
- DIAGNOSTIC SYSTEMS
- 510(k) number
- K905146
- Product code
- JQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-02-04
- Date received
- 1990-11-15
- Regulation
- 862.2050
- Classification name
- Ph Meter
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNA BENTLEY
- Address
- 480 Democrat Rd. Gibbstown NJ US 08027 08027
FDA Registration Numbers#
- 3010939897
- 3042989733
- 2030861
- 3043088937
- 3005273623
- 3043138885
- 3009880320
- 3002821232
- 3027645317
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952178 | PH-DETECT TEST | Diagnostic Reagents, Inc. | 1995-10-20 |
| K872888 | CIBA CORNING 288 PH/BLOOD GAS SYSTEM | Ciba Corning Diagnostics Corp. | 1987-08-25 |
| K770347 | METER, PH, DIGITAL, MODEL 3560 | Beckman Instruments, Inc. | 1977-04-15 |
| K770352 | METER, IV PH, MODEL EXPANDOMATIC | Beckman Instruments, Inc. | 1977-04-08 |
| K770351 | METER, IV PH, MODEL ZEROMATIC | Beckman Instruments, Inc. | 1977-04-05 |
| K760788 | PH METER-125 (.01 PH) | Corning Medical & Scientific | 1976-11-16 |
| K760789 | PH METER-130 (.001 PH) | Corning Medical & Scientific | 1976-11-16 |
Legacy Summary#
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FDA Review#
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