N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
FDA 510(k) clearance K003609 · decided 2001-05-16
Clearance details
- K-number
- K003609
- Device name
- N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
- Applicant
- Osteometer Biotech A/S
- Decision
- Substantially Equivalent
- Date received
- 2000-11-22
- Decision date
- 2001-05-16
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- NEO
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Herlev, DK
- 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 |
|---|---|---|
| ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK (K051297) | Roche Diagnostics Corp. | 2005-09-08 |
Recalls involving this device
No recalls on record reference this clearance.