The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys N-mid Osteocalcin, Elecsys Osteocalcin Calset, Elecsys Osteocalcin Calcheck.
| Device ID | K051297 |
| 510k Number | K051297 |
| Device Name: | ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK |
| Classification | System, Test, Osteocalcin |
| 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 | NEO |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-18 |
| Decision Date | 2005-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630940462 | K051297 | 000 |
| 04015630939084 | K051297 | 000 |