The following data is part of a premarket notification filed by Diagnostic Specialties with the FDA for Potassium Reagent Set.
| Device ID | K813608 |
| 510k Number | K813608 |
| Device Name: | POTASSIUM REAGENT SET |
| Classification | Tetraphenyl Borate, Colorimetry, Potassium |
| Applicant | DIAGNOSTIC SPECIALTIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEJ |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-29 |
| Decision Date | 1982-01-22 |