K051297 is an FDA 510(k) clearance for the ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK. This device is classified as a System, Test, Osteocalcin (Class II - Special Controls, product code NEO).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 8, 2005, 113 days after receiving the submission on May 18, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K051297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2005 |
| Decision Date | September 08, 2005 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NEO — System, Test, Osteocalcin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |