FDA Product Code
FDA Product Code NEO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1050
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K051297 | ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK | Roche Diagnostics Corp. | 2005-09-08 | Traditional | PDF ↗ |
| K003609 | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 | Osteometer Biotech A/S | 2001-05-16 | Traditional | PDF ↗ |
Product code NEO · Class II · Clinical Chemistry. Data: openFDA.