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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2012 | Immunodiagnostics Systems Ltd IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles.
The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Terminated |
NEO | None listed |
| Oct 10, 2012 | Immunodiagnostics Systems Ltd IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles.
The IDS-iSYS N-Mid Osteocalcin Assay is intended for the quantitative determination of Osteoca Terminated |
NEO | None listed |
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