The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Potassium Test Kit.
| Device ID | K832553 |
| 510k Number | K832553 |
| Device Name: | POTASSIUM TEST KIT |
| Classification | Tetraphenyl Borate, Colorimetry, Potassium |
| Applicant | MALLINCKRODT CRITICAL CARE 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 | 1983-08-01 |
| Decision Date | 1983-09-20 |