ADVIA CENTAUR HOMOCYSTEINE ASSAY
FDA 510(k) clearance K013406 · decided 2001-12-18
Clearance details
- K-number
- K013406
- Device name
- ADVIA CENTAUR HOMOCYSTEINE ASSAY
- Applicant
- Bayer Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-15
- Decision date
- 2001-12-18
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- LPS
- Device class
- 2
- Regulation number
- 862.1377
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. recall (Z-1822-2025) | Siemens Healthcare Diagnostics, Inc. | 2025-05-27 |
| ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, an recall (Z-1960-2014) | Siemens Healthcare Diagnostics, Inc | 2014-07-02 |