The following data is part of a premarket notification filed by Thermo Electron Corp. with the FDA for Thermo Electron Enzymatic Creatinine, Model Tr35401.
| Device ID | K061412 |
| 510k Number | K061412 |
| Device Name: | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 |
| Classification | Enzymatic Method, Creatinine |
| Applicant | THERMO ELECTRON CORP. 171 INDUSTRY DRIVE Pittsburg, PA 15272 |
| Contact | Bola Nicholson |
| Correspondent | Bola Nicholson THERMO ELECTRON CORP. 171 INDUSTRY DRIVE Pittsburg, PA 15272 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-22 |
| Decision Date | 2007-03-23 |