510(k) K051297
- Device
- ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K051297
- Product code
- NEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-09-08
- Date received
- 2005-05-18
- Regulation
- 862.1050
- Classification name
- System, Test, Osteocalcin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAY A TAYLOR
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 8031673
- 2032839
- 9612316
- 2182595
- 8021924
- 9610126
- 3007118747
Source Documents#
Other 510(k) Records For Product Code NEO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003609 | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 | Osteometer Biotech A/S | 2001-05-16 |
Legacy Summary#
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FDA Review#
Decision Summary