510(k) K031038 ยท NBC Test, Natriuretic Peptide
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 23, 2003 |
| Received | Apr 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2017 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests) Open, Classified |
NBC | None listed |
| Jun 26, 2015 | Siemens Healthcare Diagnostics, Inc SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using th Terminated |
NBC | None listed |
| Jun 26, 2015 | Siemens Healthcare Diagnostics, Inc SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using th Terminated |
NBC | None listed |
| Nov 19, 2014 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catal Terminated |
NBC | None listed |
| Dec 11, 2012 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare BNP (8-type Natriuretic Peptide)
500 Test kit 02816634
100 Test 02816138
10309045, 10309044 028
Intended Use For in vitro diagnostic use in the quantitative determination of B-ty Terminated |
NBC | None listed |
| Sep 6, 2012 | Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
Catalog Numbers:
2 Pa Terminated |
NBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.