Panels › Clinical Chemistry › Product code NEO · Class 2
System, Test, Osteocalcin
Regulation 862.1050
0510(k)s in 12 months (2 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in NEO
| Company | 510(k)s | Recalls |
|---|---|---|
| Immunodiagnostics Systems Ltd | 0 | 2 |
| Osteometer Biotech A/S | 1 | 0 |
| Roche Diagnostics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2005 | K051297 | ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK Roche Diagnostics Corp. | NEO |
| May 16, 2001 | K003609 | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 Osteometer Biotech A/S, DK | NEO |
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