The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Creatinine Standards.
| Device ID | K802631 |
| 510k Number | K802631 |
| Device Name: | CREATININE STANDARDS |
| Classification | Calibrator, Primary |
| Applicant | GILFORD DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-23 |
| Decision Date | 1980-12-11 |