NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
FDA 510(k) clearance K033727 · decided 2004-04-22
Clearance details
- K-number
- K033727
- Device name
- NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
- Applicant
- Nichols Institute Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2003-11-28
- Decision date
- 2004-04-22
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- CEW
- Device class
- 2
- Regulation number
- 862.1545
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040 recall (Z-0810-05) | Nichols Institute Diagnostics | 2005-05-10 |