The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Precicontrol Bone.
| Device ID | K051543 |
| 510k Number | K051543 |
| Device Name: | ELECSYS PRECICONTROL BONE |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Contact | Corina Haper |
| Correspondent | Corina Haper ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-10 |
| Decision Date | 2005-10-17 |
| Summary: | summary |