The following data is part of a premarket notification filed by Harleco with the FDA for Ultrachem Creatinine 64972, Centrifuchem.
| Device ID | K780514 |
| 510k Number | K780514 |
| Device Name: | ULTRACHEM CREATININE 64972, CENTRIFUCHEM |
| 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 | 1978-03-30 |
| Decision Date | 1978-05-19 |