The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for Potassium Test.
| Device ID | K811661 |
| 510k Number | K811661 |
| Device Name: | POTASSIUM TEST |
| Classification | Tetraphenyl Borate, Colorimetry, Potassium |
| Applicant | KING DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CEJ |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-15 |
| Decision Date | 1981-06-25 |