The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Potassium Reagent Set.
| Device ID | K902574 |
| 510k Number | K902574 |
| Device Name: | POTASSIUM REAGENT SET |
| Classification | Tetraphenyl Borate, Colorimetry, Potassium |
| Applicant | TECH-CO, INC. 1856 STAR-BATT DR. Rochester Hills, MI 48309 |
| Contact | Chen, Ph.d |
| Correspondent | Chen, Ph.d TECH-CO, INC. 1856 STAR-BATT DR. Rochester Hills, MI 48309 |
| Product Code | CEJ |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-11 |
| Decision Date | 1990-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002133 | K902574 | 000 |
| 10673486002157 | K902574 | 000 |