The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Elecsys- Acth,acth Calset,acth Calcheck,precicontrol Acth.
| Device ID | K060585 |
| 510k Number | K060585 |
| Device Name: | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH |
| Classification | Radioimmunoassay, Acth |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Randy Johnson |
| Correspondent | Randy Johnson ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | CKG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-07 |
| Decision Date | 2006-05-03 |
| Summary: | summary |