The following data is part of a premarket notification filed by Thermo Fisher Scientific Oy with the FDA for Creatinine (enzymatic).
| Device ID | K070824 |
| 510k Number | K070824 |
| Device Name: | CREATININE (ENZYMATIC) |
| Classification | Enzymatic Method, Creatinine |
| Applicant | THERMO FISHER SCIENTIFIC OY 2 RATASTIE Vantaa, FI 01620 |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen THERMO FISHER SCIENTIFIC OY 2 RATASTIE Vantaa, FI 01620 |
| Product Code | JFY |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-12-03 |
| Summary: | summary |