Ph-Detect Test
FDA 510(k) K952178 · Diagnostic Reagents, Inc.
510(k) numberK952178
Submission
- Device name
- Ph-Detect Test
- Applicant
- Diagnostic Reagents, Inc.
Sunnyvale, CA, US - Received
- May 9, 1995
- Decision date
- October 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JQY – Ph Meter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905146 | Olympus Urine PHJQY · Traditional | Diagnostic Systems | 02/04/1991SE |
| K872888 | Ciba Corning 288 Ph/Blood Gas SystemJQY · Traditional | Ciba Corning Diagnostics Corp. | 08/25/1987SE |
| K770347 | Meter, PH, Digital, Model 3560JQY · Traditional | Beckman Instruments, Inc. | 04/15/1977SE |
| K770352 | Meter, IV PH, Model ExpandomaticJQY · Traditional | Beckman Instruments, Inc. | 04/08/1977SE |
| K770351 | Meter, IV PH, Model ZeromaticJQY · Traditional | Beckman Instruments, Inc. | 04/05/1977SE |
| K760789 | PH METER-130 (.001 PH)JQY · Traditional | Corning Medical & Scientific | 11/16/1976SE |
| K760788 | PH METER-125 (.01 PH)JQY · Traditional | Corning Medical & Scientific | 11/16/1976SE |
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Questions and answers
When was Ph-Detect Test cleared by the FDA?
Ph-Detect Test (K952178) received a 510(k) decision of Substantially Equivalent on October 20, 1995, 164 days after the submission was received.
What is the product code of K952178?
The FDA product code is JQY – Ph Meter, a Class I (low risk) device regulated under 21 CFR 862.2050.