ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
FDA 510(k) clearance K031038 · decided 2003-06-23
Clearance details
- K-number
- K031038
- Device name
- ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
- Applicant
- Bayer Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-04-01
- Decision date
- 2003-06-23
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- NBC
- Device class
- 2
- Regulation number
- 862.1117
- 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 |
|---|---|---|
| SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro recall (Z-2149-2014) | Siemens Healthcare Diagnostics, Inc | 2015-06-26 |
| SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro recall (Z-2150-2014) | Siemens Healthcare Diagnostics, Inc | 2015-06-26 |
| ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B recall (Z-0229-2015) | Siemens Healthcare Diagnostics, Inc | 2014-11-19 |
| Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 0281613 recall (Z-0506-2013) | Siemens Healthcare Diagnostics, Inc | 2012-12-11 |
| Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur recall (Z-2313-2012) | Siemens Healthcare Diagnostics, Inc | 2012-09-06 |
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 |