1,25-DIHYDROXY VITAMIN D EIA
FDA 510(k) clearance K051110 · decided 2005-07-06
Clearance details
- K-number
- K051110
- Device name
- 1,25-DIHYDROXY VITAMIN D EIA
- Applicant
- Immunodiagnostic Systems , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-02
- Decision date
- 2005-07-06
- Days to decision
- 65 days
- Clearance type
- Abbreviated
- 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
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.