OCTEIA 25-HYDROXY VITAMIN D
FDA 510(k) clearance K021163 · decided 2002-05-10
Clearance details
- K-number
- K021163
- Device name
- OCTEIA 25-HYDROXY VITAMIN D
- Applicant
- Immunodiagnostic Systems , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-11
- Decision date
- 2002-05-10
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- MRG
- Device class
- 2
- Regulation number
- 862.1825
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Boldon, Tyne & Wear, GB
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EI recall (Z-0697-2013) | IDS (Immunodiagnostic Systems Ltd.) | 2013-01-18 |
| IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hy recall (Z-0173-2009) | Immunodiagnostics Systems Inc | 2008-10-24 |