ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
FDA 510(k) clearance K051297 · decided 2005-09-08
Clearance details
- K-number
- K051297
- Device name
- ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-18
- Decision date
- 2005-09-08
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- NEO
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 (K003609) | Osteometer Biotech A/S | 2001-05-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |