510(k) K051297
K051297 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK". The FDA issued a decision of Substantially Equivalent on September 8, 2005. The device falls under product code NEO (System, Test, Osteocalcin), a Class II device regulated under 21 CFR 862.1050. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2005
- Date Received
- May 18, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Osteocalcin
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type