The following data is part of a premarket notification filed by Thermo-electron Corp. with the FDA for Data-trol N Normal Control Serum, Data-trol A Abnormal Control Serum.
| Device ID | K052056 |
| 510k Number | K052056 |
| Device Name: | DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-29 |
| Decision Date | 2005-09-23 |