System, Test, Osteocalcin
The System, Test, Osteocalcin (product code NEO) is an in vitro diagnostic system that measures serum osteocalcin levels, a biochemical marker of bone formation used to assess bone turnover in conditions such as osteoporosis. It is classified as an FDA Class 2 device within the Clinical Chemistry specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NEO
- Device Class
- FDA class 2
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K051297 | ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK | Sep 08, 2005 | Substantially Equivalent | Roche Diagnostics Corp. |
| K003609 | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 | May 16, 2001 | Substantially Equivalent | Osteometer Biotech A/S |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.