The following data is part of a premarket notification filed by Thermo Fisher Scientific Oy with the FDA for Uric Acid (aox), Scal, Nortrol, Abtrol.
| Device ID | K073612 |
| 510k Number | K073612 |
| Device Name: | URIC ACID (AOX), SCAL, NORTROL, ABTROL |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | THERMO FISHER SCIENTIFIC OY 2 RATASTIE P.O. BOX 100 Vantaa, FI Fin-01621 |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen THERMO FISHER SCIENTIFIC OY 2 RATASTIE P.O. BOX 100 Vantaa, FI Fin-01621 |
| Product Code | JIX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-21 |
| Decision Date | 2008-05-23 |
| Summary: | summary |