VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
FDA 510(k) clearance K012367 · decided 2001-10-09
Clearance details
- K-number
- K012367
- Device name
- VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D
- Applicant
- Nichols Institute Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2001-07-26
- Decision date
- 2001-10-09
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Juan Capistrano, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. recall (Z-1118-04) | Nichols Institute Diagnostics | 2005-02-24 |