The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Tsh Calset W/models 04738551.
| Device ID | K060754 |
| 510k Number | K060754 |
| Device Name: | ELECSYS TSH CALSET W/MODELS 04738551 |
| Classification | Calibrator, Secondary |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-04-18 |
| Summary: | summary |