The following data is part of a premarket notification filed by Thermo-electron Corp. with the FDA for Oxalate Urine Controls (normal And Elevated).
| Device ID | K062521 |
| 510k Number | K062521 |
| Device Name: | OXALATE URINE CONTROLS (NORMAL AND ELEVATED) |
| Classification | Calibrator, Secondary |
| Applicant | THERMO-ELECTRON CORP. 189-199 BROWNS RD. Noble Park, Victoria, AU 3174 |
| Contact | Melita Lambiris |
| Correspondent | Melita Lambiris THERMO-ELECTRON CORP. 189-199 BROWNS RD. Noble Park, Victoria, AU 3174 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2007-03-16 |