TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
FDA 510(k) clearance K053020 · decided 2005-12-30
Clearance details
- K-number
- K053020
- Device name
- TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
- Applicant
- Bayer Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-10-26
- Decision date
- 2005-12-30
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- 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 Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Produc recall (Z-2207-2015) | Siemens Healthcare Diagnostics, Inc | 2015-07-23 |
| ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 a recall (Z-1991-2014) | Siemens Healthcare Diagnostics, Inc | 2014-07-02 |
| ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, recall (Z-0580-2008) | Siemens Medical Solutions Diagnostics | 2008-06-05 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018) | Bayer Healthcare, LLC | 2004-12-22 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030) | Bayer Healthcare, LLC | 1998-12-08 |
| CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001) | Bayer Healthcare, LLC | 1995-12-13 |