The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Total Protein.
| Device ID | K781774 | 
| 510k Number | K781774 | 
| Device Name: | TOTAL PROTEIN | 
| Classification | Biuret (colorimetric), Total Protein | 
| Applicant | GILFORD DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | CEK | 
| CFR Regulation Number | 862.1635 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1978-10-13 | 
| Decision Date | 1978-11-22 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TOTAL PROTEIN  85826834  4515897 Live/Registered | Jay Cutler Elite, LLC 2013-01-18 |