The following data is part of a premarket notification filed by Thermo Electron Corporation with the FDA for Datapro Clinical Chelistry Analyzer.
| Device ID | K042767 |
| 510k Number | K042767 |
| Device Name: | DATAPRO CLINICAL CHELISTRY ANALYZER |
| Classification | Hexokinase, Glucose |
| Applicant | THERMO ELECTRON CORPORATION 331 SOUTH 104TH STREET Louisville, CO 80027 |
| Contact | Bola Nicholson |
| Correspondent | Bola Nicholson THERMO ELECTRON CORPORATION 331 SOUTH 104TH STREET Louisville, CO 80027 |
| Product Code | CFR |
| Subsequent Product Code | CDO |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CIC |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CIX |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CKA |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-05 |
| Decision Date | 2005-04-27 |
| Summary: | summary |