The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Ph-detect Test.
| Device ID | K952178 |
| 510k Number | K952178 |
| Device Name: | PH-DETECT TEST |
| Classification | Ph Meter |
| Applicant | DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale, CA 94086 |
| Product Code | JQY |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-09 |
| Decision Date | 1995-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011663 | K952178 | 000 |
| 00884883005532 | K952178 | 000 |
| 00884883005525 | K952178 | 000 |
| 00884883005518 | K952178 | 000 |
| 00884883005501 | K952178 | 000 |
| 00884883005495 | K952178 | 000 |
| 00884883002999 | K952178 | 000 |