FDA 510(k) Applications for Medical Device Product Code "NBC"
(Test,Natriuretic Peptide)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K033606 | AXIS-SHIELD DIAGNOSTICS, LTD. | ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST | 01/30/2004 |
| K040425 | BAYER HEALTHCARE, LLC | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS | 06/14/2004 |
| K043228 | BAYER HEALTHCARE, LLC | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS | 04/22/2005 |
| K031038 | BAYER HEALTHCARE, LLC | ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY | 06/23/2003 |
| K051265 | BAYER HEALTHCARE, LLC | ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY | 06/13/2005 |
| K032525 | BAYER HEALTHCARE, LLC | BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER | 09/09/2003 |
| K073091 | BIOMERIEUX, INC. | VIDAS NT-PROBNP ASSAY, MODEL: 30 449 | 02/29/2008 |
| K032235 | BIOSITE INCORPORATED | MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | 01/28/2004 |
| DEN000010 | BIOSITE INCORPORATED | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | 11/20/2000 |
| K021317 | BIOSITE INCORPORATED | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | 07/01/2002 |
| K010266 | BIOSITE INCORPORATED | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 | 03/16/2001 |
| K052789 | BIOSITE INCORPORATED | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | 01/23/2006 |
| K033383 | BIOSITE INCORPORATED | TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 | 12/23/2003 |
| K051787 | BIOSITE INCORPORATED | TRIAGE BNP TEST, MODEL 98000XR | 09/22/2005 |
| K030286 | BIOSITE INCORPORATED | TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL | 02/21/2003 |
| K080269 | BIOSITE INCORPORATED | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | 06/06/2008 |
| K041417 | DADE BEHRING, INC. | DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 | 07/20/2004 |
| K061795 | DADE BEHRING, INC. | DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR | 09/11/2006 |
| K071767 | DADE BEHRING, INC. | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A | 08/04/2007 |
| K042347 | DADE BEHRING, INC. | MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD | 11/19/2004 |
| K071834 | DADE BEHRING, INC. | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM | 08/17/2007 |
| K043476 | DADE BEHRING, INC. | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT | 02/15/2005 |
| K060964 | FUJIREBIO DIAGNOSTICS, INC. | ARCHITECT BNP ASSAY, MODEL 8K28 | 05/25/2006 |
| K192380 | Fujirebio Diagnostics, Inc. | ST AIA-PACK BNP | 08/24/2020 |
| K053597 | I-STAT CORPORATION | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) | 07/21/2006 |
| K072189 | MITSUBISHI KAGAKU IATRON | PATHFAST NTPROBNP AND D-DIMER TESTS | 02/05/2008 |
| K051596 | NANOGEN, INC. | STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 | 03/13/2006 |
| K201312 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | 10/04/2021 |
| K060632 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 | 06/06/2006 |
| K063662 | RESPONSE BIOMEDICAL CORP. | RAMP NT-PROBNP ASSAY | 07/21/2008 |
| K210546 | Roche Diagnostics | Elecsys proBNP II, Elecsys proBNP II STAT | 03/31/2022 |
| K223637 | Roche Diagnostics | Elecsys proBNP II, Elecsys proBNP II STAT | 07/21/2023 |
| K072437 | Roche Diagnostics | ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET | 02/05/2008 |
| K092649 | ROCHE DIAGNOSTICS CORP. | ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 | 02/04/2010 |
| K022516 | ROCHE DIAGNOSTICS CORP. | ELECSYS PROBNP IMMUNOASSAY | 11/19/2002 |
| K051382 | ROCHE DIAGNOSTICS CORP. | ELECSYS PROBNP IMMUNOASSAY | 12/05/2005 |
| K032646 | ROCHE DIAGNOSTICS CORP. | ELECSYS PROBNP IMMUNOASSAY | 11/12/2003 |
| K082645 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 | 09/22/2008 |
| K080578 | Siemens Healthcare Diagnostics Inc. | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA | 05/16/2008 |
| K220265 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur« NT-proBNPII (PBNPII) | 09/24/2023 |
| K211199 | Tosoh Bioscience, Inc. | ST AIA-PACK BNP Assay | 11/08/2021 |
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