The following data is part of a premarket notification filed by Harleco with the FDA for Ultrachem Creatinine.
| Device ID | K770819 |
| 510k Number | K770819 |
| Device Name: | ULTRACHEM CREATININE |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-04 |
| Decision Date | 1977-07-11 |